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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); Physical Asymmetry (4573)
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: song, j. H. , et al. (2021), unstable lateral hinge fracture or occult complete osteotomy adversely affects correction accuracy in open-wedge high tibial osteotomy, arthroscopy: the journal of arthroscopic and related surgery, vol. Xx, pages 1-10 (south korea) the purpose of this study is to verify whether lateral hinge fracture (lhf) affects correction accuracy in open-wedge high tibial osteotomy (owhto) and to identify the fracture characteristics responsible for inaccurate correction, including lhf type and hinge location. Between 2010 and 2016, 148 patients with a mean age of 53. 4 +/ 8. 6 years (range, 25-70 years) underwent open-wedge high tibial osteotomy (owhto) using a tomofix (depuy synthes, bettlach, switzerland). The mean follow-up duration was 49. 7 +/ 21. 8 months (range, 24-102 months). The following complications were reported as follows: 41 cases showed lateral hinge fracture (lhf) -32 cases had type 1 lhf -7 cases had type 2 lhf -2 cases had type 3 lhf 11 cases showed inappropriate correction 2 cases were converted to total knee arthroplasty at 6 and 7 years after owhto, respectively. This report is for an unknown synthes tomofix. A copy of the literature article is being submitted with this medwatch. This report is for one (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 Key12547537
MDR Text Key273817825
Report Number8030965-2021-08119
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeKS
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
1 Patient was Involved in the Event
Date FDA Received09/29/2021
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 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

Patient Treatment Data
Date Received: 09/29/2021 Patient Sequence Number: 1
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