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Catalog Number SD800.428
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/28/2018
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). Initial reporter is synthes sales consultant. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 europe reports an event in (b)(6) as follows: it was reported patient underwent a cranioplasty with a synthes patient specific implant (psi) polyetheretherketone (peek) implant on (b)(6) 2018. After the procedure was completed, the surgeon stated that the peek implant did not fit exactly to the defect. No patient consequence was reported. Concomitant devices: cmf plate (part unknown, lot unknown, quantity unknown), cmf screw (part unknown, lot unknown, quantity unknown). This report is for one (1) psi peek implant. This is report 1 of 1 for (b)(4).
Manufacturer Narrative
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 the 06. 04. 2018. 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 frontal bilateral defect. The implant in scope of this investigation is positioned on the right 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 1 mm. The 1 mm offset was mentioned on the approval document. 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. 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. Timing: (b)(6) 2018: 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; 23. 04. 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; 28. 09. 2018: the surgery was conducted; (b)(6) 2018 the complaint pc-(b)(4). Was reported. 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 and verified as per the design instructions. No design defect or deficiency potentially contributed to the complaint condition have been identified. The device was shipped on may 4, 2018. However, the surgery was recorded for sep. 28, 2018. As per our ct scan protocol, the protocol states: warning: patient specific devices will be designed to fit the patient anatomy at the time of the ct or cbct scan. Changes in the patient anatomy occurring after the ct or cbct scan, as well as the use of the device after such changes, may result in a suboptimal fit of the device or implant. This non-manufacturing investigation is therefore closed by product development as non-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 NamePSI SD800.428 PEEK IMPLANT
Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key8007531
MDR Text Key125109922
Report Number8030965-2018-57667
Device Sequence Number1
Product Code GXN
UDI-Device Identifier07611819341319
Combination Product (y/n)N
PMA/PMN Number
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 10/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSD800.428
Device Lot NumberL879620
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Is This a Reprocessed and Reused Single-Use Device?