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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 Hematoma (1884); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - peek implant/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. 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: zhang, q. Et al (2018), a large multicenter retrospective research on embedded cranioplasty and covered cranioplasty, world neurosurgery, vol. 112 (xx), pages e645-e651 (china). The aim of this multicenter retrospective cohort study is to compare the clinical outcomes and complications of embedded cp and covered cp. Between january 2014 to march 2017, a total of 185 patients were included in the study. Surgery was performed using peek implants depuy synthes, (b)(4) and competitor; peek group in 75 patients (62 male and 13 female) with a mean age of 33. 27 ¿ 14. 26 years, while titanium implant from competitor (titanium group) in 110 patients (82 male and 28 female) with a mean age of 37. 57 ¿ 15. 41 years. The mean follow-up duration of peek group and titanium group is 13. 5 ¿ 4. 9 months and 14. 2 ¿ 6. 9 months, respectively. The following complications were reported as follows: peek group: the rate of overall complications is 13 (17. 3%). 6 patients had subgaleal effusion. Of these 6 patients, 5 were cured by wrapping their heads in elastic bandages after having the fluid drawn out with a syringe. Having tried this method several times on the sixth patient, the refractory subgaleal effusion was still not cured. Eventually, the situation was improved after we performed lumbar drainage. Unfortunately, this patient subsequently acquired severe surgical site infections, and the ineffectiveness of antibiotics left us with no choice but to remove the implants. Another patient with the same subgaleal effusion was cured by the intravenous infusion of antibiotics. 1 patient had postoperative epidural hematoma because of postoperative low platelets in her blood. After communicating with her family members, they decided not to allow us to perform hematoma evacuation surgery. This patient was eventually cured with conservative therapy. 2 patients had surgical site infections. 3 patients had postoperative new seizures. 3 patients had postoperative hematoma. 1 patient had implant exposure. 1 patient underwent reoperation. 4 patients had poor outcome. 56 patients had no brain function improvement. In 5 out of 10 patients, the seizure did not disappear. This report is for one (1) an unknown synthes peek implant. This is report 1 of 1 for complaint (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 Key11680631
MDR Text Key245988609
Report Number8030965-2021-03006
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 03/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2021
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 Received03/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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