MAUDE Adverse Event Report: SYNTHES GMBH TI LOCKING SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 04.614.508

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Drug Resistant Bacterial Infection (4553); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Concomitant medical products: date of concomitant therapy is (b)(6) 2021.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.(b)(4).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

Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent revision surgery due to a migrated rod.The surgeon commented the following: 1.The setscrews on both ends of the plate had come off.2.The rod was about to protrude from the occipital region.3.The surgeon confirmed that final screw tightening during the primary procedure was performed.The patient underwent primary posterior cervical fusion in the occipital bone for treating vestibular neuronitis on december 8, 2021.The procedure was completed without surgical delay.On (b)(6) 2022, the surgeon reported that the rod might have come off.This report is for a titanium (ti) locking screw.This is report 2 of 3 for (b)(4).Additional reports are captured under (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.H3, h4, h6: part # 04.614.508, lot # 64p2152, manufacturing site: werk selzach, release to warehouse date: 11 nov2020, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the ti locking screw shows markings consistent with the implantation and explanation of the device.No other irregularity or defects were observed on the returned device.No post-operative images to assess the migration condition were provided.A dimensional inspection was performed for the ti locking screw and met specifications.Major thread diameter and height were inspected using micrometer mitutoyo.The minor thread diameter was inspected using zz plus vermont gauge pin gage set.A functional test was not conducted since the mating device was not returned for examination.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the ti locking screw was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.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

Although there is no loosening of implants, mrsa infection is confirmed.The surgeon commented that the patient's son is on the verge of suing for lack of explanation from the manufacturer about implant problem.

• Brand Name: TI LOCKING SCREW
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14701220
• MDR Text Key: 294911090
• Report Number: 8030965-2022-04008
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034739229
• UDI-Public: (01)10705034739229
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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
• Device Operator: Health Professional
• Device Model Number: 04.614.508
• Device Catalogue Number: 04.614.508
• Device Lot Number: 64P2152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 06/20/2022; 02/20/2023
• Supplement Dates FDA Received: 07/18/2022; 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: OCCIPITAL-PL 4.5/5 MED W/50 F/R Ø4 TI; TI LOCKING SCREW - STERILE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female