MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 40; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Model Number 199721640

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

Patient Problems Neurological Deficit/Dysfunction (1982); Paralysis (1997); Injury (2348); Unspecified Nervous System Problem (4426)

Event Type  Injury  

Manufacturer Narrative

510k: 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 4 of 10 for (b)(4).Related product complaints: (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 information: d6: implant date updated.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.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.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: 5.5 EXP VERSE SCREW 6.0 X 40
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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 ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 10045022
• MDR Text Key: 193730623
• Report Number: 1526439-2020-00999
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034442280
• UDI-Public: 10705034442280
• 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: 199721640
• Device Catalogue Number: 199721640
• 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: 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE SCREW 6.0 X 40; 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