MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 6X40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186731640

Device Problem Migration (4003)

Patient Problem Paralysis (1997)

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that this was a spinal fusion (l4 to s) for the lumbar spinal canal stenosis on (b)(6) 2022.The surgery was completed successfully with more than 30 minutes delay.After the surgery, paralysis remained.Postoperative ct showed that the left screw of l4 backed out slightly inward.The cause of residual paralysis is unknown whether it was due to insufficient decompression or screw back-out.Therefore, a revision surgery was performed on (b)(6) 2022.According to the surgeon, this event was not the product problem, but a result of the insertion point being inside.No further information is available.This report is for one (1) 5.5 ti cort fix 6x40mm this is report 1 of 1 for complaint (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.Procode: additional product codes: kwp, mni, kwq and mnh.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: 5.5 TI CORT FIX 6X40MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: kate karberg ; chemin-blanc 38; le locle ; 3035526892
• MDR Report Key: 16184768
• MDR Text Key: 307498624
• Report Number: 1526439-2023-00074
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034351827
• UDI-Public: (01)10705034351827
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186731640
• Device Catalogue Number: 186731640
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male