MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PATIENT SPECIFIC IMPLANT PEEK/ EXPRESS; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD899.999

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

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient ref.# (b)(6).This report is for a patient specific implant peek/ express/ lot numbers are unknown; udi number is unknown.Occupation: synthes employee.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.Product was not returned.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 on an unknown date that the patient went thorough an adverse incident with 3 mini plates and 6 implanted screws.On (b)(6) 2012 the patient presented a small asymmetry in the plasty psi, as well as in one of the screws of the titanium lower plate that had been released.The same cranioplasty is replaced again, but 4 months later another of the screws is released with the result of another intervention and has an infection altering the bone and osteosynthesis material.Patient was re-operated by placing the same plasty psi and using a greater number of plates to ensure anchoring on (b)(6) 2012.In (b)(6) 2014 a skin lesion occurs due to continuous rubbing by a screw and intervened again with the same plasty procedure.But it does not fit properly.In (b)(6) 2018 the patient underwent a surgery to replacement of 6 new screws.The patient was experienced infection, non-union, allergic reaction, pain, and osteoporosis, etc.This report is for a patient specific implant peek/ express.This is report 8 of 10 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.Code 3191 used to capture surgical intervention and fracture nonunion.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

This report is linked to (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.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

The peek plasty psi was not fixed properly and there was mobility.Re-operation was performed with new screws.

• Brand Name: PATIENT SPECIFIC IMPLANT PEEK/ EXPRESS
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9458272
• MDR Text Key: 185713077
• Report Number: 8030965-2019-71074
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K033868
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD899.999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention