MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PSI IMPLANTS; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

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

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

Event Type  Injury  

Manufacturer Narrative

Additional patient identifier #: (b)(6).510k: this report is for an unknown psi implant/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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.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 that the patient experienced the adverse incident with a patient specific implants (psi).Initially on an unknown date the patient was implanted with a peek plasty psi with 3 mini plates and 6 screws.Postoperatively on (b)(6) 2012 the patient presented a small asymmetry in the plasty psi, as well as one of the screws of the titanium lower plate had been released.The same cranioplasty was replaced, however 4 months later another screw was released which resulted in another intervention and had an infection altering the bone and osteosynthesis material.On (b)(6) 2012 cranial ct scan is performed again because plasty psi mobility is objective.On (b)(6) 2012 patient was re-operated by placing the same plasty psi and using a greater number of plates to ensure anchoring.On (b)(6) 2014, a skin lesion occured due to a continuous rubbing by a screw and is intervened again and with the same plasty psi.The plasty psi does not fit 100% correctly, but they decide not to change it.On (b)(6) 2018 patient was re implanted with 6 new plates.Patient outcome is unknown.This report captures the post-op event where 4 months later another screw was released which resulted in another intervention and had an infection altering the bone and osteosynthesis material.Related complaint pc (b)(4) captures the (b)(6) 2012 event of small asymmetry in the plasty psi as well as release of one of the screws.Related complaint pc (b)(4) captures the (b)(6) 2012 event regarding plasty psi mobility and re-operation on (b)(6) 2012.Related complaint pc (b)(4) captures the (b)(6) 2014 event regarding a skin lesion.Related complaints pc (b)(4), pc (b)(4) capture (b)(6) 2018 event of re-implantation.This report is for an unknown patient specific implant.This is report 1 of 3 for complaint pc (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.Corrected data: this report is adverse event only, no product problem reported.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: UNK - PSI IMPLANTS
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9503960
• MDR Text Key: 188069427
• Report Number: 8030965-2019-71297
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention