MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.426 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.426

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

Patient age/date of birth and weight are unknown.Due to intra-operative issues, the device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4) used to capture the change in the surgical plan to use titanium mesh instead.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 europe reports an event in (b)(6) as follows: it was reported that the surgical guide and the patient specific peek implant did not fit to patient's anatomy.The guide seemed much larger than the implanted.The surgeon was not able to use the cutting guide and tried to resect the patient¿s cranium without it.The implant was not the shape or thickness the surgeon was expecting.He tried to use the implant, but in the end titanium mesh was used.Reportedly there was a surgical delay but the length of the delay was not provided.Concomitant devices reported: patient specific guide cranial forehead (part sd900.108, lot me18-luc-zik_01 and me18-luc-zik_02, quantity 2).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.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.Part sd800.426, lot l863780: release to warehouse date: april 17, 2018.Manufacturing site: (b)(4).No non-conformance reports (ncrs) were generated during production.Review of the device history records (dhr) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: the patient specific implant referred has been received not in original packaging: information etched on product matches the dhr and complaint system.No evidence of nonconformance manufacturing related identified.The functionality of the involved implant has been investigated with respect to the complaint condition.The functional match has been confirmed per the inspection sheet.Differently from the complaint description, the fit to patient's anatomy has been confirmed by functional match through the perimeter template and no manufacturing related issue was identified.The manufacturing investigation is disposed as unconfirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative 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 SD800.426 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: 7498886
• MDR Text Key: 107743670
• Report Number: 8030965-2018-53642
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341197
• UDI-Public: (01)07611819341197
• 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,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.426
• Device Lot Number: L863780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention