MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI 100*80*40 PEEK; PLATE,CRANIOPLASTY,PREFORMED,NONALTERABLE

Catalog Number SD800.427

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Date of event is unknown.Explant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter name and telephone number.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient specific implant (psi) does not fit well with the bone.Specifically, for the temporal or orbital rim.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: country code, date of manufacture.Dhr review was completed.Part number: sd800.427, lot number: l788424, manufacturing location: (b)(4), release to warehouse date: 19 february 2018.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.Customer quality conducted an investigation based on the information received, as no device was returned.The psi implant was not received for investigation as it remains implanted.The received information was sent to the responsible biomaterials engineer (b)(4) for investigation.The bellow summary is an abstract of the attached pd investigation.During a visit of the (b)(4) product manager in (b)(4) the case was discussed first with the sales team and later with the treating surgeon.Within this discussion it became clear, that the surgeon and the local sales team where not completely aware of the colour coding in the images for approval.In addition, the surgeon explained that the bone above the nasal cavity could not been removed, as this was a bone transplant from a previous operation, that did close the nasal cavity.It was a quick established, common agreement, that in future cases the colour coding will be considered better during the approval process of peek psi and that it is more efficient for the surgeon to request a design change in such a case, rather than adjust the implant intraoperatively.However, the intraoperative adjustment of the peek psi is a known and approved way to improve the fit of the implant according the intraoperative situation.The surgeon also did confirm, the achieved result after the operation that was prolonged about 45¿ and that was performed and completed with the adjusted peek psi in question was good for the surgeon as well as for the patient.Based on the provided information we were able to determine the root cause of the complaint and address it with the related discussion and training of the local sales force and the treating surgeon.Complaint actions based on the above discussed situation the root cause has been identified and addressed with the local organization.Complaint conclusion based on the above evaluation, the complaint will be closed as not valid, as there was no process- or product failure detected for the product design and production phase.However, the complaint can be confirmed as the described intraoperative findings could be followed in the complaint investigation.The dhr review shows that the production procedure was according to the specifications at the manufacturing time in february 2018 and there were no issues that would contribute to this complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is appropriate.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

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.Device has not been reported as explanted.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.

• Type of Device: PLATE,CRANIOPLASTY,PREFORMED,NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7393356
• MDR Text Key: 104442233
• Report Number: 8030965-2018-52727
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341302
• UDI-Public: (01)07611819341302(10)L788424
• 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,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.427
• Device Lot Number: L788424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1