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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); Necrosis (1971); Physical Asymmetry (4573)
Event Date 07/02/2021
Event Type  Injury  
Manufacturer Narrative
510k: 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: takahara, t. Et al. (2021), mid-term results of medial open-wedge high tibial osteotomy based on radiological grading of osteoarthritis, archives of orthopaedic and trauma surgery, vol. Xx, pages 1-10 (japan). The purpose of this study is to evaluate the mid-term results of medial open-wedge high tibial osteotomy (owhto) based on kellgren¿lawrence (kl) grades. Between january 2010 and march 2014, 93 patients (109 consecutive knees) with medial compartment osteoarthritis (oa) underwent owhto using a tomofix plate (depuy-synthes, solothurn, switzerland) the mean age of the patients was 61. 4 years, the 1mean follow-up was 64. 2 months, the following complications were reported as follows: 3 patients had delayed bone union. 22 patients had hinge fractures. 26 patients had osteoarthritis progression. 17 cases had undercorrection. 7 cases had overcorrection. 2 patients had additional surgeries. Unicompartment arthroplasty was done for 1 case because of necrosis of medial femoral condyle after owhto. Re-osteotomy was done for 1 case because of overcorrection and increasing tibial posterior slope. This report is for an unknown synthes tomofix. This report is for one (1) unk - constructs: tomofix plate/screws. This is report 1 of 1 for (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 Key12547238
MDR Text Key273800721
Report Number8030965-2021-08117
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
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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