MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.540 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number	SD800.540
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D4: udi: as the serial and lot number for the device involved in the event was not clear, the full udi is currently not available.Lot # provided is not a valid number.Therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
Event or Problem Description
It was reported, that on july 16, 2024.The item did not fit, due to soft tissue interference.Implant was about 1cm prominent on defect.There was a soft tissue overlay that did not allow for fit.It is unknown, if there was a surgical delay.Procedure and patient outcome were unknown.This report is for one (1) psi sd800.540 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.H11 additional narrative: added: a2, a3b, a4 corrected: h1 (type of reportable event), h6 (health effect - impact code & health effect - clinical code) 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.
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: added: d9.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics send the device to r&d team conducted an investigation bases on the returned implant.Implant was returned and is generally in good condition.All etching is clear and visible, there is no apparent discoloration, cracking or deformation of the implant.There are 8 small holes drilled along the perimeter of the implant consistent with intra-operative preparation for fixation with screws and plates per the intended use of the device.Although intra-operative modification of the implant shape with a burr is allowed per the ifu, there are no markings on the implant that would indicate that happened in this case.The functional test cannot replicate the complaint conditions because within the text of the complaint, it is clear that the reason for the poor fit was soft tissue interference rather than inappropriate design of the implant related to bony fit the implant was verified to fit to the appropriate bony anatomy of the patient and was therefore designed appropriately.Soft tissue defects can change quickly and are outside of the scope of the psi design process to accommodate.The reported poor fit of this device was due to a soft tissue issue therefore there is no defect in the implant itself.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the psi sd800.540 peek implant 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 history review: product code: sd800.540.Lot number: 27729p0.Manufacturing site: jabil inc.Brandywin.Release to warehouse july 09, 2024.A manufacturing record evaluation was performed for the not sterile finished lot number, 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: PSI SD800.540 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: 19978174
• Report Number: 8030965-2024-09911
• Device Sequence Number: 2781718
• Product Code: GXN
• UDI-Device Identifier: 10887587065991
• UDI-Public: (01)10887587065991
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K053199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SD800.540
• Device Lot Number: 6660719 ENV4691632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 08/19/2024; 03/24/2025; 03/26/2025
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/06/2024; 03/25/2025; 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Unknown
• Patient Weight: 82 KG