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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown psi implants/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 experienced 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 was replaced again, but four months later another of the screws released with the result of another intervention and infection altering the bone and osteosynthesis material.The patient was re-operated by placing the same plasty psi and using a greater number of plates to ensure anchoring on (b)(6) 2012.On (b)(6) 2014 a skin lesion occurred due to continuous rubbing by a screw which was intervened again with the same correction procedure.The plasty procedure was attempted but the device did not fit properly.On (b)(6) 2018 the patient underwent a procedure for replacement of 6 new screws.The patient experienced infection, non-union, allergic reaction, and pain.No further information provided.This report is for one (1) unk - psi implants.This is report 1 of 3 for (b)(4).This (b)(4) captures the events for (b)(6) 2012 regarding a cranial ct scan that was performed again because plasty psi mobility was objective.And (b)(6) 2012 regarding a re-operation by placing the same plasty psi and using a greater number of plates to ensure anchoring.Elape (b)(4) captures the (b)(6) 2012 event.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 was replaced again.(b)(4) captures the unknown post-op event involving the same cranioplasty that was replaced again, but 4 months later another of the screws was released with the result of another intervention and had an infection altering the bone and osteosynthesis material.(b)(4) captures the (b)(6) 2014 event regarding a skin lesion that occured due to a continuous rubbing by a screw and was intervened again and with the same plasty psi.The plasty psi does not fit 100% correctly, but they decide not to change it.(b)(4) captures nine (9) devices, while (b)(4) captures ten (10) devices.

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.E1: facility name, address & reporters state: (b)(6).H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.

• 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: 9505687
• MDR Text Key: 188352930
• Report Number: 8030965-2019-71310
• 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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention