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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PEEK IMPLANT PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772); Post Operative Wound Infection (2446)
Event Type  Injury  
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. This is report 1 of 4 for (b)(4).
 
Manufacturer Narrative
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.
 
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Brand NameUNK - PEEK IMPLANT
Type of DevicePLATE, 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 Key14249991
MDR Text Key290379632
Report Number2939274-2022-01531
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
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