MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SET SCREW; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	102000000S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that almost all inner screws from a symphony construction detached from the head of the screw.The first surgery was on (b)(6) 2024 and in post op exam it was verified that construction failed with the loose locking screws.Almost all pedicle screws remained on place.Non union was also noted.The patient underwent revision surgery, which went well.
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.H11 additional narrative: added: d4 (lot, expiry date), d9, d10 (concomitant), h4.Corrected: d4 (primary udi number).H3, h6: the device was received, the investigation is in progress, 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.
Additional 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.H3, h4, h6 the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found no damage or defect was found over the surface of the device.Additionally, a functional test was performed with the mating devices (102035112s and 102064080) and no problem with assembly was found.Surgical technique symphony oct system was reviewed and the following relevant statements were found at page 13 and 14: note: the reducer kerrison helps ensure the rod is fully seated in the saddle before final tightening.Precaution: care should be taken to avoid using excessive force during rod reduction steps that may undermine bony purchase and result in screw pullout.Precautions: the screw inserters are not intended for use in final tightening.Damage to set screwdriver feature may occur.Always fully reduce rod in all bone anchors prior to final tightening.Failure to use provided 3.0nm torque limiting handle when final tightening may lead to set screw back out.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the set screw would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review a manufacturing record evaluation was performed for the finished device product code: 102000000s.Lot number: 408868.The product was released on: 23 sep 2024.Manufacturing site: jabil le locle.Expiry date: 31 jul 2029.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SET SCREW
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW 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 ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 21180076
• Report Number: 1526439-2025-00079
• Device Sequence Number: 12942198
• Product Code: NKG
• UDI-Device Identifier: 10705034526799
• UDI-Public: (01)10705034526799(17)290731(10)408868
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K181949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 102000000S
• Device Lot Number: 408868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 02/13/2025; 03/05/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/18/2025; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.0 PLY SCRW 3.5X12.; 4.0 PLY SCRW 3.5X12.; 4.0 PLY SCRW 3.5X12.; TI 4.0X080 LOR ROD.; TI 4.0X080 LOR ROD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male