MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI 100*100*40 PEEK; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.433

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient ref.# (b)(6).This report is for an unk - psi/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Initial reporter is company representative.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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 a patient presented on (b)(6) 2012, with a small asymmetry in the plasty of the patient specific implant (psi), as well as in one of the screws of the titanium lower plate that had migrated.A revision was required and occurred on an unknown date concomitant device reported: unknown plate (part # unknown, lot # unknown, quantity # 1), unknown screws (part # unknown, lot # unknown, quantity # unknown).This is report 1 of 2 for (b)(4).This report is for an unknown patient specific implant for cranioplasty.This complaint is linked to (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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

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.Facility name, address & reporters state: (b)(6).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.

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: 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 part number: sd800.433, lot number: 3816404 (case (b)(4)), manufacturing site: mezzovico, release to warehouse date: 23.May 2011.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.

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.

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: the device was not returned.The investigation was performed by product development (pd).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 16.02.2011 (see ¿timing¿).The skull of this case showed a frontal 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 3 mm.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: 16.02.2011: the ct scan was performed , 11.04.2011: the case data was received by depuy synthes r&d (case id 211204) , 11.04.2011: the case has been created in the trumatch cmf internal case management system (with the id 211204).14.04.2011: the design has been completed and the approval letter was sent to the sales rep.27.04.2011: surgeon approval was signed and received 23.05.2011: the manufacturing files were checked and released for production 23.05.2011: the device was produced 24.05.2011: the device was shipped not known: initial surgery was conducted 22.11.2019: the complaint (b)(4) was reported.22.11.2019: the complaint (b)(4) was reported.Per the description above the psi case file was reviewed.The investigation included a review of the documentation and forms along with the surgeon report.The design was completed and verified as per the design instructions.The not 100% fit of the device described in complaint (b)(4) captures the (b)(6) 2014 which is more than three years after the initial implantation cannot be explained by pd with the provided information.No design defect or deficiency potentially contributed to the reported complaint conditions have been identified.This non-manufacturing investigation is therefore closed by product development as undetermined 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.

• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9503713
• MDR Text Key: 188504736
• Report Number: 8030965-2019-71296
• Device Sequence Number: 1
• Product Code: GXN
• 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: 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.433
• Device Lot Number: 3816404
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention