MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.439 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.439

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Event occurred on an unknown date in 2021.Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date in 2021 during an unknown procedure, the patient underwent surgery with the psi peek implants in question.After closing, post surgery germs were detected and a revision surgery was performed.There was no allegation against the device.The procedure was completed without surgical delay.This report is for one (1) psi sd800.439 peek implant.This is report 2 of 2 for (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.H10 additional narrative: h6: part: sd800.439, lot: 86p7079, manufacturing site: mezzovico, release to warehouse date: january 22, 2021.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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 SD800.439 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11385768
• MDR Text Key: 242847891
• Report Number: 8030965-2021-01402
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341371
• UDI-Public: (01)07611819341371
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.439
• Device Lot Number: 86P7079
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2021
• Patient Sequence Number: 1
• Treatment: PSI SD800.439 PEEK IMPLANT.
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR