MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.440 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED,NONALTERABLE

Catalog Number SD800.440

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier, age, date of birth, and weight not available for reporting it is not known if the device was implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes sales consultant 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 during a cranioplasty procedure on (b)(6) 2018, the patient specific implant (psi) polyether ether ketone (peek) implant did not fit well.The anterior portion of the implant was not aligned to the bony edge and was slightly higher.It is not known if the device was implanted.This report is for one (1) psi sd800.440 peek implant.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Design review: an investigation was conducted into the device design to determine if the design contributed or caused the event.The ct scan information of this case was shared with depuy synthes r&d on the march 8, 2018 (¿timing¿).The ct scan met the requirements specified in the ct/cbct scan protocol to continue with the implant design.The skull of this case showed a defect on the right patient side.The design for the implant was created according to the relevant work instruction for psi design.The implant was designed with a standard thickness of 4 mm and an offset from the psi to the defect of 1 mm.On march 14, 2018, a temporal cut was requested by the surgeon via the sales representative.The implant design was updated with a reduced contact area in the temporal region.The temporal cut feature as well as the 1 mm offset was mentioned on the approval document.Additional verification of potential interference of the psi with the skull in the ct scan (with mimics v17) was performed.No interference with the bone could be detected.Review of the case file ¿patient specific implant design review checklist¿ for this implant showed that the implant was reviewed and approved by an independent reviewer according to the relevant work instruction for psi design.Timing: per the description above the psi case file was reviewed.The investigation included a review of the documentation, forms, digital model (cad) files, along with the surgeon report.The design was completed and verified as per the design instructions.No design defect or deficiency potentially contributed to the complaint condition have been identified.Conclusion: the complaint was not confirmed during investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

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.A device history record review was performed for the subject device: part number: sd800.440.Lot number: l849929 , manufacturing location: mezzovico , release to warehouse date: 06 april 2018.No nonconformances (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.No ncr's were generated during production that would contribute to the complaint condition.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 SD800.440 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: 7507322
• MDR Text Key: 108019064
• Report Number: 8030965-2018-53712
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341388
• UDI-Public: (01)07611819341388
• 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: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.440
• Device Lot Number: L849929
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1