MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.440 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number	SD800.440
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
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.: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h6: 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.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
It was reported that, during cranioplasty.The surgeon found the customized peek implant was unable to fit patient's skull defect.The surgeon had to modify the skull-bone, this was a size issue and claimed that more than 5mm skull had been modified.After modified and implantation, there was still some uneven.The procedure time expanded about 45 mins.Patient status is unknown and has been discharged.The surgery was completed successfully, this report is for one (1) psi sd800.440 peek implant.This is report 1 of 1 for complaint (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.Additional narrative: a1: patient id reported as hl, ct2184693.H6: part: sd800.440 lot: 8424p07 manufacturing site: mezzovico.Release to warehouse date: 27 october 2023 a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.Non-sterile part: sd800.440 lot: 11361p2 manufacturing site: mezzovico.Release to warehouse date: 11 march 2024 a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.The product was not returned to depuy synthes for evaluation.The r&d team conducted an investigation based off the case records and complaint documentation.Per the investigation performed above the psi case file communication were reviewed.The investigation included an end-to-end process review of the documentation and forms along with the surgeon complaint description and the received details on the case.No intra / post-operatively images were provided with the complaint.No case specific features or increased off set between the patient bone and implant was requested.The implant design was completed and verified as per the depuy synthes design instructions and roles.After the surgeon reviewed the design and approved it with his signature on the approval letter, the device was produced and inspected according to process and released upon acceptable quality inspection.Based on the information and documents available this design investigation is closed as not valid regarding a design related root cause.As a part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the psi sd800.440 peek implant.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.H6 component code: g07002 ¿ device not returned.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 SD800.440 PEEK IMPLANT
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19168593
• Report Number: 8030965-2024-05349
• Device Sequence Number: 15441168
• Product Code: GXN
• UDI-Device Identifier: 10887587065113
• UDI-Public: (01)10887587065113
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SD800.440
• Device Lot Number: 8424P07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown