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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.435 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
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OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.435 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE Back to Search Results
Catalog Number SD800.435
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/24/2018
Event Type  Injury  
Manufacturer Narrative
Patient¿s weight is not provided for reporting.Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The surgeon attempted to implant the patient specific implant but was unable due to dimensions.The surgeon closed the and rescheduled the procedure.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 that during a surgery on (b)(6) 2018, the patient specific implant could not be implanted due to insufficient flattening.It did not fit properly and skin was not possible to be closed.The device was not implanted.After this the product specific peek implant (psi) was successfully implanted on (b)(6) 2018, however it had to be removed due to wound dehiscence on (b)(6) 2018.A new implant with larger flattening is needed.This report addresses the issue of patient specific implant which did not fit properly during the surgery performed on (b)(6) 2018.The patient specific implant removal due to wound dehiscence has been captured under linked complaint (b)(4).This report is for one (1) psi sd800.435 peek implant.This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
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.Device history records review was completed for part# sd800.435, lot# l701951.Manufacturing location: mezzovico, release to warehouse date: dec 14, 2017.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this 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.
 
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: 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 09.11.2017.The ct scan did not meet the requirements as specified in the ct/cbct scan protocol.However, the surgeon approval was received to continue with this provided patient scan.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, an offset from the psi to the defect of 0.2 mm, a temporal cut and a slight reduction (flattening) of the outer device surface when compared to the mirrored surface of the native bone as requested by the surgeon.The unmet ct scan requirements and the temporal cut were mentioned and communicated to the surgeon on the approval document.Additionally, a verification of potential interference of the psi with the skull in the ct scan (with mimics v17) was performed.No interference with the bone has been 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.The signed approval letter was received on 06 dec.2020 without any additional comments and the production process was initiated.Timing: first device timeline under complaint: (b)(4); (b)(6) 2017: the ct scan was performed; (b)(6) 2017: the case data was received by depuy synthes r&d; (b)(6) 2017: the case has been created in the trumatch cmf internal case management system; (b)(6) 2017: the design has been completed and the approval letter was sent to the sales rep.; (b)(6) 2017: surgeon approval was signed and received; (b)(6) 2017: the functional check device was printed and checked by an independent engineer; (b)(6) 2017: the manufacturing files were checked and released for production; (b)(6) 2017: the device was produced; (b)(6) 2017: the device was shipped; (b)(6) 2018: the surgery date.(unsuccessful implantation of the device); (b)(6) 2018: the complaint (b)(4) was reported; second device timeline under complaints : (b)(4)/ (b)(4); (b)(6) 2017: the ct scan was performed; (b)(6) 2018: the case data was received by depuy synthes r&d; (b)(6) 2018: the case has been created in the trumatch cmf internal case management system; (b)(6) 2018: the design has been completed and the approval letter was sent to the sales rep.; (b)(6) 2018: surgeon approval was signed and received; (b)(6) 2018: the functional check device was printed and checked by an independent engineer; (b)(6) 2018: the manufacturing files were checked and released for production; (b)(6) 2018: the device was produced; (b)(6) 2018: the device was shipped; (b)(6) 2018: the second surgery date; (b)(6) 2018: the removal surgery date; (b)(6) 2018: the complaint (b)(4) (see separate evaluation) was reported as well as the first complaint was reported again by the customer and recorded under complaint (b)(4).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 following the work instructions and verified as per the instructions.No design defect or deficiency potentially contributed to the complaint condition have been identified.This non-manufacturing investigation is therefore closed by product development as not valid regarding a design related root cause.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.
 
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Brand Name
PSI SD800.435 PEEK IMPLANT
Type of Device
PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7404384
MDR Text Key104669176
Report Number8030965-2018-52849
Device Sequence Number1
Product Code GXN
UDI-Device Identifier07611819341357
UDI-Public(01)07611819341357(10)L701951
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,Followup
Report Date 03/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSD800.435
Device Lot NumberL701951
Was Device Available for Evaluation? No
Date Manufacturer Received06/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
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