MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.434 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.434

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in china as follows: it was reported that on (b)(6) 2023, during the surgery of cranioplasty, surgeon found that the psi curve was too large, which causing the edges to overlap on the bones and can not be tightly closed.Surgeon had to complete the surgery with the issued peek.Till now, the patient was still under observation in hospital.The surgery was successfully completed without any surgical delay.There is no plan for another surgery to address/correct the issue this report is for one (1) psi sd800.434 peek implant.This is report 1 of 1 for complaint (b)(4).

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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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.

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, h4, h6 the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device the following design investigation was conducted by trumatch product engineering.Please refer to "(b)(4) complaint investigation_signed".Per the complaint description above, the psi case files and communication were reviewed.The investigation included an endto-end process review of the documentation and forms along with the surgeon complaint report and the received details on the case.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), 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 for the initial device is closed as not valid regarding a design related root cause.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was unconfirmed for psi sd800.434 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.H4, h6 part number: sd800.434, lot number: 7596p81, manufacturing site: mezzovico, release to warehouse date: 25 aug.2023.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.

• Brand Name: PSI SD800.434 PEEK IMPLANT
• Type of Device: 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 17830510
• MDR Text Key: 324461715
• Report Number: 8030965-2023-12264
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341340
• UDI-Public: (01)07611819341340
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.434
• Device Lot Number: 7596P81
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1