MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.442 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.442

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).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 germany reports an event as follows: it was reported that on (b)(6) 2017 that the patient was treated with a psi (patient specific implant) for a fixation with craniofix.The patient developed bacterial meningitis with empyem and the psi was explanted on (b)(6) 2020.Patient was in intensive care but stable.The patient will be implanted with a new psi.This report is for one (1) psi sd800.442 peek implant.This is report 1 of 3 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.H3, h4, h6 investigation summary 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 history part: sd800.442, lot: l278142, manufacturing site: mezzovico, release to warehouse date: 18.Jan.2017.A manufacturing record evaluation was performed for the finished device 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 SD800.442 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9973569
• MDR Text Key: 196567743
• Report Number: 8030965-2020-02922
• Device Sequence Number: 1
• Product Code: GXN
• 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: 04/14/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.442
• Device Lot Number: L278142
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 04/17/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 05/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention