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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - PEEK IMPLANT PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
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 1 of 3 for (b)(4).
 
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Brand NameUNK - PEEK IMPLANT
Type of DevicePLATE, 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 Key11740086
MDR Text Key263366661
Report Number8030965-2021-03391
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
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 Received04/28/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
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