MAUDE Adverse Event Report: SYNTHES GMBH CRANIAL-PL 1.6 STRAIG W/CENT-SPACE 2HO T; PLATE, BONE

Catalog Number	421.502S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported this case is from the health authority.The patient had surgery with plates and screws one and a half years ago.He recovered well and was discharged half a month later.However, 10 months later, the patient reported that the head prosthetic material was exposed, the scalp was defective, and a small amount of yellowish fluid was spilled on the exposed area.A second surgery was performed and the patient was discharged 10 days later with good recovery.Two months later, the patient had swelling and pain in the right temporal region for another week, and examination revealed effusion and blood.A third surgical procedure was then performed and the scalp was incised and approximately 5 cm in length with a large gush of fluid.It was considered that the infection could not be controlled, so the plate was removed and the patient recovered well.A fourth repair surgery is scheduled this month.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Additional information received: the event date should update to be 05-sep-2025.After investigation, the patient was implanted with peek skull plate of other company, and titanium plate and titanium nail from j&j (code: 421.502s, 400.834.04s, specific application unknown) for skull repair during the surgery.The hospital reported that the surgery went smoothly.Since the patient had repeated infection at the skull repair site about one year after the surgery, the doctor removed the implant and scheduled a secondary procedure.No subsequent adverse event reports were received.
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.  h11 additional narrative: added: b5, d10 concomitant corrected: g1 manufacturer site, e1 facility name   h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary = > 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 lot = > part: 421.502s lot: 256l852 manufacturing site: werk selzach supplier: früh verpackungstechnik ag release to warehouse date: 01 dec 2023 expiration date: 01 dec 2033 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.--------------------------------------------------------------------- non-sterile part # 421.502 non-sterile lot # 7772p19 manufacturing site: werk selzach supplier: depuy synthes products, inc release to warehouse date: 06 sep 2023 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CRANIAL-PL 1.6 STRAIG W/CENT-SPACE 2HO T
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25209602
• Report Number: 8030965-2026-04675
• Device Sequence Number: 18783088
• Product Code: JEY
• UDI-Device Identifier: 10887587050362
• UDI-Public: (01)10887587050362(17)331201(10)256L852
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 421.502S
• Device Lot Number: 256L852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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: CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown