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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 Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). This report is for an unk - screws: spine/unknown lot. Part and lot numbers are unknown; udi 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 as no product was received. The investigation could not be completed, no conclusion could be drawn at the time of filing this report. Product was not returned. Based on the information available, it has been determined that no corrective and 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: this report is being filed after the review of the following journal article: jonkergouw j. , et al (2016) outcome in patient-specific peek cranioplasty: a two-center cohort study of 40 implants, journal of cranio-maxillofacial surgery volume 44, pages 1266-1272 (netherlands). Http://dx. Doi. Org/10. 1016/j. Jcms. 2016. 07. 005. This retrospective study aims to evaluate patient- and surgery-related characteristics and risk factors that predispose patients to an increased risk of complications after peek cranioplasty. From 2011 to 2014, 38 consecutive patients (23 males, 15 females) with average age at peek cranioplasty was 43. 2 ± 18. 1 years (range 8e84) who underwent 40 peek cranioplasties in the academic medical center amsterdam (24 cranioplasties) and the st elisabeth hospital tilburg (16 cranioplasties). Peek implants used were (xilloc medical bv, maastricht, the netherlands, 29 cranioplasties; depuy synthes, zuchwil, switzerland, 7 cranioplasties; 3di gmbh, jena, germany, 4 cranioplasties). The median follow-up period was 19. 1 months (iqr 12. 5e30. 6). The following complications were reported: 11 peek implants complications were seen in 11 patients. Complications consisted of infection (n
=
5), haematoma (n
=
4), csf leak (n
=
1) and wound-related problems (n
=
1). Five peek implants were removed due to infection. In three of these patients the same psi was reused after sterilization after 1. 8, 3. 8 and 8. 0 months, without further complications. Two patients refused re-implantation and consequently a permanent loss of peek cranioplasty was seen in 5%. Ten cranioplasties (25%) required additional surgery. One patient with a postoperative (subgaleal) haematoma received conservative treatment, without the need for additional surgical intervention. Postoperative subcutaneous seroma formation was observed in four cases and resolved spontaneously in all. This report is for an unknown synthes peek implant. This report is for (1) unk - peek implant. This report is 1 of 1 (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 Key11562738
MDR Text Key242696769
Report Number8030965-2021-02248
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
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 Received03/04/2021
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? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/24/2021 Patient Sequence Number: 1
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