MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 35; BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE

Model Number 199721635

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neurological Deficit/Dysfunction (1982); Paralysis (1997); Unspecified Nervous System Problem (4426)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported on an unknown date, on (b)(6) 2015, the patient presented with the complaints of shoulder pain which revealed scoliosis obtained on radiological studies.However, they failed to diagnose scoliosis or have the patient scoliosis evaluation.On (b)(6) 2018, the patient came with the complaints of upper back pain primarily in the left-mid-thoracic spine radiating to the left and right buttocks.The pain was intermittent, moderate ache with no history of back pain before.On (b)(6) 2018, the patient explained that he had low back pain and occasional thigh pain.The patient denied of radiating pain, numbness or tingling in her extremities.The patient was scheduled then with posterior instrumented fusion t2 to l4 vertebral bodies.The need for the surgery was urgent because it was not detected earlier.On (b)(6) 2018, the surgeon recommended and agreed to have urgent surgery to the patient with more conservative treatment.On (b)(6) 2018, they began the surgery (posterior instrumented fusion t2 to l4.But when the patient awoke from the surgery, the patient was completely paralyzed from her chest down with the motor-sensory loss from t4 to her toes.And now suffers from dysreflexia.This complaint involves sixty-four (64) devices.This is a report of one (1) unknown mono/polyaxial screws.This is report 8 of 10 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Subsequent follow-up with the customer, additional information was received.Regarding the event.Therefore, the tests/lab data including dates and medical history/preexisting condition have been updated accordingly.The product code was unknown on the initial report; and has been updated accordingly.Therefore, the brand name, common device name, procode, catalog number, lot number, and udi have been updated accordingly.The implantation date was inadvertently missed on the previous report; and has been updated to reflect the correct information.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: d2: additional product codes: osh, kwq, mni, nkb, and kwp.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additionally it was reported that on (b)(6) 2018 patient a subsequent removal of spinal hardware including bilateral rods, t2 hooks bilaterally, right t5 screw and left t9 and t10.This intervention was noted for partial correction of patient's deformity.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part/lot combination is not valid, and device is not being returned, therefore, dhr could not be completed.If the device is returned or lot number can be confirmed, the dhr will be revisited.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that there was no damage or defects with the 5.5 exp verse screw 6.0 x 35.There is not enough evidence in the x-ray to confirm the allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 5.5 exp verse screw 6.0 x 35.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.B6: tests/lab data updated.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2: additional procodes: osh, kwq, mni, nkb, kwp.D6: date of implantation added.G4: 510(k) added.H6: investigation codes added.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that there was no damage or defects with the 5.5 exp verse screw 6.0 x 35.There is not enough evidence in the x-ray to confirm the allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 5.5 exp verse screw 6.0 x 35.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.D1: device brand name updated.D2: common device name and procode updated.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d6: device implantation date added.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that there was no damage or defects with the 5.5 exp verse screw 6.0 x 35.There is not enough evidence in the x-ray to confirm the allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 5.5 exp verse screw 6.0 x 35.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that there was no damage or defects with the 5.5 exp verse screw 6.0 x 35.There is not enough evidence in the x-ray to confirm the allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 5.5 exp verse screw 6.0 x 35.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 EXP VERSE SCREW 6.0 X 35
• Type of Device: BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10043667
• MDR Text Key: 193319072
• Report Number: 1526439-2020-00977
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034442297
• UDI-Public: 10705034442297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/27/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 199721635
• Device Catalogue Number: 199721635
• Device Lot Number: 317609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE SCREW 6.0 X 35; 5.5 EXP VERSE SCREW 6.0 X 35; 5.5 EXP VERSE SCREW 6.0 X 35; 5.5 EXP VERSE SCREW 6.0 X 35; 5.5 EXP VERSE SCREW 6.0 X 35; 5.5 EXP VERSE SCREW 6.0 X 35; 5.5 EXP VERSE SCREW 6.0 X 35; 5.5 EXP VERSE SCREW 6.0 X 35; 5.5 EXP VERSE SCREW 6.0 X 35; UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN MONO/POLYAXIAL SCREWS
• Patient Outcome(s): Required Intervention
• Patient Sex: Female