MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.440 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.440

Device Problem Defective Device (2588)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/07/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 reports an event in (b)(6) as follows: it was reported that the patient's indication was bilateral skull defects.During the surgery on (b)(6) 2019 for skull repair, surgeon noted that the peek implant did not completely match the patient's skull defect, the size did not match, some margins.There was a gap with the defect skull.The surgeon needed to extract autogenous bone to supplement, some margins: larger than the defect skull, the surgeon needed to grind down.The surgery was delayed for about two (2) hours.The patient is stable now.This report is for one (1) psi (b)(4) peek implant this is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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, 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.H3, h4, h6: a device history record.Device history lot.No combination could be found for part # sd800.440 with lot # 21p6343, therefore a dhr review could not be performed at this time.If further information becomes available regarding the identifies for this part, then this dhr review will be revisited.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 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

The procedure was successfully completed.

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, h6: dhr information reviewed: device history review.P/n: sd800.440, lot: 21p6343, manufacturing site: mezzovico , release to warehouse date: october 31, 2019.A manufacturing record evaluation was performed for the not sterile 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.

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.The device was not returned.The investigation was performed by product development (pd).Refer to attachment ¿(b)(4) pd complaint investigation_cs_signed¿.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 the sep 30, 2019.The ct scan met the requirements specified in the ct/cbct scan protocol (document j12505-a dsem/cmf/1214/0050(1) 09/17) to continue with the implant design.The skull of this case showed a bilateral defect.The design for both implants (left and right) was created according to the relevant work instruction for psi design (w-c-s030 rev.1).The implants were designed for both sides with a standard thickness of 4 mm and an offset from the psi to the defect of 0.2 mm.The approval document (plm windchill document number 500350666) 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¿ (plm windchill document number 500350667) for these implants showed that the implants were reviewed and approved by an independent reviewer according to the relevant work instruction for psi design (w-c-s030 rev.1).Additional verification of potential interference of both psis (left and right) 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.

• Brand Name: PSI SD800.440 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9591495
• MDR Text Key: 189141105
• Report Number: 8030965-2020-00372
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341388
• UDI-Public: (01)07611819341388
• Combination Product (y/n): N
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.440
• Device Lot Number: 21P6343
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR