MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.402 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Patient id: (b)(6).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Health effect clinical code (b)(4) used to capture patient code injury.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, a patient underwent a revision of a peek implant because as per surgeon this implant was implanted wrong and therefore new 3d implant was produced and implanted.No further information provided.This report is for one (1) psi sd800.402 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.Photo investigation: the part was not returned for investigation, hence a photo investigation was completed on the images.There was no issue with the implant based on the images provided and it should be noted that event description mentions the doctor had no allegation for the implant as this is a user error.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.Conclusion: the complaint condition cannot be confirmed.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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 SD800.402 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11890778
• MDR Text Key: 256167503
• Report Number: 8030965-2021-04330
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819337749
• UDI-Public: (01)07611819337749
• Combination Product (y/n): N
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention