MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VERSE CORRECTION KEY; SCREW, FIXATION, BONE

Model Number 199721000

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

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Paralysis (1997); No Code Available (3191); Unspecified Nervous System Problem (4426)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown locking/set screws /unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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 that 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 (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the other 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received and (b)(4) capture the 4 out of 64 devices reported/received.This report is for one (1) unknown locking/set screws this report is 4it was reported that 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 (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the other 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received and (b)(4) capture the 4 out of 64 devices reported/received.This report is for one (1) unknown locking/set screws.This report is 3 of 10 for (b)(4).It was reported that 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 (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received, (b)(4) capture the other 10 out of 64 devices reported/received, (b)(4) capture the 10 out of 64 devices reported/received and (b)(4) capture the 4 out of 64 devices reported/received.This report is for one (1) unknown locking/set screws.This report is 8 of 10 for (b)(4) 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.H11: corrected data: g4: awareness date reported on follow up 1 report as may 04, 2020 but should have been may 25, 2020.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

Product complaint # (b)(4).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.H3, h6: investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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

Product complaint (b)(4).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.H10 additional narrative: e3: reporter is a synthes rep.H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.H11: d6/ capture correct date of implant.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.H10: additional narrative: d2: additional product codes: mni, kwp, nkb, kwq, and osh.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: b5.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.

• Brand Name: VERSE CORRECTION KEY
• Type of Device: SCREW, FIXATION, BONE
• 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 10044907
• MDR Text Key: 195391952
• Report Number: 1526439-2020-01006
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10705034466132
• UDI-Public: 10705034466132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

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: 199721000
• Device Catalogue Number: 199721000
• Device Lot Number: 317609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2022
• 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: VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY
• Patient Outcome(s): Required Intervention
• Patient Sex: Female