MAUDE Adverse Event Report: SYNTHES GMBH PATIENT SPECIFIC IMPLANT PEEK/ EXPRESS; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD899.999

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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 that on (b)(6) 2020, the patient specific implant did not fit the patient and needed to be shaped with a burr.There is no further information available.This report is for one (1) patient specific implant peek/ express.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d6a.Date of implant: (b)(6) 2020.E1: added dr.(b)(6) as initial reporter reporters state: (b)(6).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, h6: the product was not returned to depuy synthes for evaluation.The r&d team conducted an investigation based off the case records and complaint documentation.Device design: an investigation was conducted into the device design to determine if the design contributed or caused the issue as described in the complaint description.The initial request noted confirmation of ct scan date, size, and location of the defect on request cmf design document - psi-surgeon approval letter, this design was confirmed in the psi-design review checklist: (cmf design document, psi-design review checklist.A secondary case was initiated, and an approval latter was sent but never returned/approved by the surgeon.Therefore, the secondary request was canceled.Electronic device design review: the design review of the patient scan data received and that of the final psi device concluded that the psi device fit and matched the patient situation with no mismatch identified.All requested features and changes were implemented in that final design.Design process review: the psi device ifu states that modification of the implant by the surgeon is allowed and considered as on label use.The review of the design for he implant was created according to the relevant work instruction for psi design.The 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.Per the investigation description above, the psi case files, communication, design feature request, intra-operative image and post-operative scan were reviewed.The investigation included a review of the documentation and forms along with the surgeon complaint report.The design of the device was completed and verified as per the depuy synthes design instructions and roles.The surgeon approved with his signature on the approval latter the device that was designed appropriately for this case.This complaint investigation did not identify a design defect or deficiency which potentially contributed to the reported complaint conditions.Therefore, this non-manufacturing investigation is closed by product development as not valid regarding related root cause.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the patient specific implant peek/ express.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: PATIENT SPECIFIC IMPLANT PEEK/ EXPRESS
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11072215
• MDR Text Key: 223612457
• Report Number: 8030965-2020-09954
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD899.999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention