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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TRUMATCH PLATE,FIXATION,BONE

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SYNTHES GMBH UNK - PLATES: TRUMATCH PLATE,FIXATION,BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Nerve Damage (1979)
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown plates: trumatch/ 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

Device report from synthes reports an event in the (b)(6) as follows: this report is being filed after the review of the following journal article: anabtawi m, thomas m, and lee nj (2021), the use of interlocking polyetheretherketone (peek) patient-specific facial implants in the treatment of facial deformities. A retrospective review of ten patients, journal of oral and maxillofacial surgery, vol. 79 (xx), pages 1145. E1-1145. E9 (united kingdom). This retrospective study aims to present our experience in the use of interlocking peek patient-specific implants (psis) in different areas of the face. A total of 10 patients (6 male and 4 female) with a mean age of 34. 8 years (range 17-54 years) were included in the study. Surgery was performed using peek patient-specific implants (psi; depuy synthes, oberdorf, switzerland) fixed with 2, matrixmidface or matrixmandible titanium, screws (depuy synthes); however, if the implant had an excellent fitting surface, 1 screw could suffice. 2 patients had mandibular psis in combination with a centralizing/ rotation genioplasty using a titanium patient-specific guide and patient-specific plate (materialise, leuven, belgium). The mean follow-up period was 37. 1 months (range 11 to 61 months). The following complications were reported as follows: a (b)(6) year-old male patient (with 2 psi implanted) developed recurrent right maxillary sinus infection manifested by facial swelling but no signs of infection around the implant. A ct scan showed an entirely obliterated maxillary sinus with a fixation screw protruding into the sinus cavity. After a referral to ear, nose, and throat surgery, the patient was treated successfully with functional endoscopic sinus surgery, the implant remained in situ, and no further complications 3 years after functional endoscopic sinus surgery. A (b)(6) year-old female patient (with 2 psi implanted) had residual subcutaneous swelling over her right zygoma. A (b)(6) year-old male patient (with 3 psi implanted) had bilateral altered sensation in the distribution of the mental nerve with a 3-part mandibular implant. This report is for an unknown synthes unknown trumatch plates. This is report 1 of 14 for (b)(4).

 
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Brand NameUNK - PLATES: TRUMATCH
Type of DevicePLATE,FIXATION,BONE
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 Key12353195
MDR Text Key267676996
Report Number8030965-2021-07036
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUK
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 07/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received07/25/2021
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: 08/23/2021 Patient Sequence Number: 1
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