MAUDE Adverse Event Report: SYNTHES GMBH UNK - PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown peek implant/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between (b)(6) 2000 and (b)(6) 2016.Complainant part is not expected to be returned for manufacturer review/investigation.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

This report is being filed after the review of the following journal article: binhammer, a.Et al.(2020), comparative cost-effectiveness of cranioplasty implants, plastic surgery, vol.28(1), pages 29-39 (canada) the aim of this study was to compare operative duration and total hospital costs incurred for patients undergoing elective cranioplasty with a variety of materials, including manually shaped autogenous bone graft and titanium mesh, custom patient-specific titanium mesh, polymethyl methacrylate (pmma) acrylic, and polyetheretherketone (peek) implants.Between january 2000 and july 2016, a total of 119 patients underwent elective cranial vault reconstruction with autologous split skull bone graft, manually shaped or custom patient-specific titanium implants, pmma, or peek.11 patients had custom peek implants (depuy synthes, raynham, massachusetts).There were 6 males and 5 females for peek implant patients.The following complications were reported as follows: 5 patients had complications of which 3 required surgical intervention 1 patient had poor contour.1 patient had implant exposure.1 patient had infection.This report is for an unknown synthes peek a copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown peek implant.This is report 2 of 3 for (b)(4).

• Brand Name: UNK - PEEK IMPLANT
• 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: 11740262
• MDR Text Key: 264048986
• Report Number: 8030965-2021-03393
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2021
• 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