MAUDE Adverse Event Report: SYNTHES GMBH 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	04.613.516S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter facility name: (b)(6).H3, h4, h6: 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 history review (dhr): part # 04.613.516s lot # 7l67240 manufacturing site: werk selzach logistik release to warehouse date: 10.Dec.2020 expiration date: 01 dec 2030 supplier: (b)(4) a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part: part number: 04.613.516 lot number: 78p0710 manufacturing site: mezzovico release to warehouse date: 30 nov 2020 a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.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 or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6), 2023, the patient underwent an anterior cervical fusion for ossification of the posterior longitudinal ligament.The surgery was completed successfully without any surgical delay.After the surgery, there was no problem on inspection in (b)(6) 2022.The screws in question are currently loose.Also, the plate in question is floating a few millimeters forward from the vertebrae.The patient is scheduled for removal and re-fixation on (b)(6), 2023.The plate will be shortened by 2mm, and the screw will be increased by 2mm from 16mm to 18mm.The patient status was reported to be stable.This report involves one 4.0mm ti cerv self-retain scr slf-drlg/variable angle 16mm.This is report 3 of 5 for (b)(4).

• Brand Name: 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach 2425 ; SZ 2425
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18290137
• Report Number: 8030965-2023-15485
• Device Sequence Number: 6190157
• Product Code: KWQ
• UDI-Device Identifier: 10705034737645
• UDI-Public: (01)10705034737645
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 04.613.516S
• Device Lot Number: 7L67240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L16; CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L16; CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L16; VECTRA-PL 4/4.5 2 SEGMENTS L47 TAN BLUE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male