MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This report is being filed after the review of the following journal article: ben-shalom, n.Et al.(2022), cranioplasty with customized craniofacial implants and intraoperative resizing for single-stage reconstruction following oncologic resection of skull neoplasms, the journal of craniofacial surgery, vol.33, pages 1-7 (usa).By publishing our results, in combination with our previous experiences we aim to provide significant insight and support to the growing body of literature using computer-aided designed implants for single-stage resection and reconstruction of skull invading tumors.Between 2010 and 2018, a total of 56 patients underwent resection of skull neoplasms and subsequent cranioplasty reconstruction using customized implants.Materials respective manufacturers included peek (synthes, west chester, pa, kallidium, connecticut), opaque pmma/porous polyethylene (stryker- kalamazoo mi,) and clear pmma (longevity, hunt valley, md).In all cases, the extent of the skull resection was larger than anticipated, therefore all implants were designed with an oversized diameter size and in cases where there was still a gap, segments of low-profile titanium mesh were used (stryker inc.¿ kalamazoo, mi and synthes ¿ west chester pa).The average patient age was 53.7 years (range 21¿85, sd 16.2).Postoperatively, all 56 patients reported high satisfaction following surgery and were followed up in the clinic for an average duration of 365 days (range 2 ¿ 1640 days).The article did not specify which of the devices were being used to capture the following complications: -1 patient died during the follow-up period from a cause unrelated to the tumor and/or surgery.-5 patients had tumor recurrence -scalp dehiscence -pneumocephalus -csf leak -surgical site infection -extrusion of implant this report is for an unknown synthes peek implant.A copy of the literature article is being submitted with this medwatch.This is report 3 of 4 for (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Pma/510k: this report is for an unknown peek implant/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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.

• Brand Name: UNK - PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14250170
• MDR Text Key: 290446931
• Report Number: 2939274-2022-01533
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• 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