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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)
Event Date 08/24/2020
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - constructs: tomofix plate/screws/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: winkler p. , et al (2020) a hinge position distal to the adductor tubercle minimizes the risk of hinge fractures in lateral open wedge distal femoral osteotomy, knee surgery, sports traumatology, arthroscopy xxxx , pages 1-10 (germany). This study aims to evaluate the incidence and morphology of medial cortical hinge fractures in lowdfo. Between 2015 and 2019, 127 consecutive patients who underwent low-dfo for symptomatic valgus malalignment were screened for eligibility for this retrospective observational cohort study. A total of 100 (40 males, 60 females) age 31. 3 ± 12. 7 (15¿64 years) patients were included in the present study. A locking compression plate, peekpower ¿ plate (arthrex inc. , naples, fl, usa) or tomofix¿ plate (depuy synthes, raynham, ma, usa), was used to secure the osteotomy gap. The following complications were reported as follows: the overall incidence of medial cortical hinge fractures in low-dfo was n
=
46 (46%) with 21 males and 25 females. The most frequently observed fracture type was extension of the osteotomy gap (76%), followed by a proximal (20%) and distal (4%) course of the fracture line in relation to the hinge. Group comparison (hinge fracture vs. No hinge fracture) showed statistically significant higher values for the height of the osteotomy gap (p
=
0. 001). 2 infection with hinge fracture. 2 non-union. 1 traumatic femur fracture with hinge fracture. This report is for an unknown synthes tomofix¿ plate. This report is for (1) unk - constructs: tomofix plate/screws. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameUNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS
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 Key12547825
MDR Text Key273997392
Report Number8030965-2021-08125
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
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 08/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
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 Received08/31/2021
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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