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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Event Description
This report is being filed after the review of the following journal article: miettinen, s. S. Et al (2022), survival and failure analysis of 167 medial opening wedge high tibial osteotomy with a locking titanium plate, orthopaedics & traumatology: surgery & research, vol. Xx (xx), pages 1-22 (finland). The purpose of this retrospective study was to evaluate the mid-term survival of the patients who underwent mowhto with the locking plate as a treatment for oa of the medial knee compartment. A total of 167 knees (155 patients; 138 male and 29 female) with a mean age of 48. 1 years (sd 7. 9, range 16. 0 ¿ 60. 5) who were operated with medial open wedge high tibial osteotomy (mowhto) between a study period from 01. 01. 2006 to 31. 12. 2014 were included in the study. Surgery was performed using a precountered titanium locking compression plate (tomofix¿, synthes, umkirch, germany). The osteotomy gap was filled in 50/167 (30%) knees by an iliac crest bone graft (autograft) or freeze-dried corticocancellous structural grafts (allograft) and, in some cases, with bone substitutions (competitor device; dbx putty¿, synthes inc. , west chester, pa, usa; and chronos¿, synthes, umkirch, germany). The mean follow-up time was 7. 7 (sd 2. 7, range 0. 9¿14. 5) years. The following complications were reported as follows: 8 patients (10 knees) died. 7/167 (4%) knees had intraoperative complications which were lateral cortex fracture and were treated conservatively with six weeks limited or non-weight-bearing status. Only 1 of these knees underwent subsequent revision in which the implant was removed due to irritation 1. 1 years after mowhto. 12 knees had minor adverse events: superficial infection (n
=
7), mild persistent pain (n
=
4), and delayed union (n
=
1). 39 knees had major adverse events: moderate/hard persistent pain or implant irritation (n
=
33), anterior cruciate ligament insufficiency (n
=
2), nonunion (n
=
2), and deep infection (n
=
2). 58 knees had revision surgery: implant removal due to medial knee pain (n
=
20), total knee arthroplasty (n
=
32), anterior cruciate ligament reconstruction (n
=
2), nonunion (n
=
2), and deep infection (n
=
2). This report is for an unknown synthes tomofix medial high tibia plate/screws constructs. This is report 1 of 2 for complaint (b)(4).
 
Manufacturer Narrative
Additional narrative: 510k: this report is for an unknown constructs: tomofix plate/screws: medial high tibia/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. D9: 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.
 
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Brand NameUNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13905283
MDR Text Key293186261
Report Number8030965-2022-01947
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2022
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
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/25/2022 Patient Sequence Number: 1
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