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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.419 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
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OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.419 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE Back to Search Results
Catalog Number SD800.419
Device Problem Defective Component (2292)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 11/18/2019
Event Type  Injury  
Manufacturer Narrative
Pma/510k: device is not distributed in the united states but is similar to device marketed in the usa.Investigation summary.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot.(b)(6): dhr review completed in mez on jan 09, 2020.Part: sd800.419.Lot: 21p0060.Manufacturing site: (b)(4).Release to warehouse date: october 16, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 during a skull repair surgery, doctor noted the peek implant did not completely match the patient's skull defect, the size did not match.Some margins: there was gap with the defect skull, the surgeon needed to extract autogenous bone to supplement.Some margins: larger than the defect skull and the surgeon needed to grind down.The surgery delayed about 2 hours.The patient is stable now.This is report 1 of 1 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.H3, h4, h6: part: sd800.419, lot: 21p0060, manufacturing site: mezzovico, release to warehouse date: 16 october 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 provided to depuy synthes r&d on 19-sep-2019.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 left 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 0.2 mm.The approval document was created with a disclaimer for adolescent patients calling out the following information: ¿attention, be aware that an adolescent patient will grow whereas the psi will not! appropriate follow-up is therefore essential.¿ 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.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.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.H6: code 3191 used to capture surgical intervention.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.
 
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Brand Name
PSI SD800.419 PEEK IMPLANT
Type of Device
PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9587762
MDR Text Key175088496
Report Number8030965-2020-00361
Device Sequence Number1
Product Code GXN
UDI-Device Identifier07611819341166
UDI-Public(01)07611819341166
Combination Product (y/n)N
PMA/PMN Number
K053199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSD800.419
Device Lot Number21P0060
Was Device Available for Evaluation? No
Date Manufacturer Received04/13/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age8 YR
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