MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.527 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number	SD800.527
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a custom peek implant that was implanted by surgeon.The patient has recently come back with an infection.Surgeon believes the patient had the infection for a number of reasons but does not blame the infection solely on the implant.The patient did not undergo removal of the products.The surgeon performed a cranial washout where he burred the exterior surface of the implant and applied a large amount of beta dine and saline to the infected area.This report involves one (1) psi sd800.527 peek implant.This is report 1 of 3 for (b)(4).
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: b3: only event year is known.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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: PSI SD800.527 PEEK IMPLANT
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19770156
• Report Number: 8030965-2024-08862
• Device Sequence Number: 12956380
• Product Code: GXN
• UDI-Device Identifier: 10887587065861
• UDI-Public: (01)10887587065861
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SD800.527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNK - PLATES: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female