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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 Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown tomofix construct/unknown lot. Part and lot number 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: kocialkowski c, et al. (2021), return to work after medial opening wedge high tibial osteotomy, journal of arthroscopy and joint surgery, volume 8, pages 193-201 (b)(6). The main objective of this study was to evaluate the return to work following medial opening-wedge high tibial osteotomy in our institution. Between 2004 and 2016, 42 patients (46 procedures) who underwent medial opening wedge high tibial osteotomy procedures for medial compartment knee osteoarthritis, medial joint pain, and varus malalignment were included in the study. The mean patient age was 46 years (range 33- 63) and 37 patients were male. The synthes tomofix plate was used in 36 procedures while the competitor¿s plate was used in 10. Postoperatively, patients underwent routine rehabilitation and were allowed to weight bear as tolerated. For the outcome assessment, patients received a questionnaire to assess work related function, overall quality of life and satisfaction with surgery by reporting how likely they would be to undergo the operation again. Additionally, the questionnaire included information about their type of employment and their return to work postoperatively. The article did not specify which patients were implanted with the synthes devices. Thus, complications will be reported as follows: 3 patients subsequently underwent knee arthroplasty (1 total knee arthroplasty and 2 unicompartmental knee arthroplasties). These revision procedures occurred at a mean 3. 9 years (range 3-4. 8 years) after the index high tibial osteotomy. 11 patients subsequently underwent removal of metalwork due to soft tissue irritation. 5 patients had superficial infection which responded to oral antibiotics. 1 patient had deep wound infection which required removal of metalwork and application of a circular external fixation. 1 patient had non-union which required revision high tibial osteotomy and bone graft. 1 patient had a pulmonary embolism which was treated with anticoagulation. This report is for the synthes tomofix locking plate system. 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 Key12548230
MDR Text Key274222101
Report Number8030965-2021-08129
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,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/01/2021
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 Received09/01/2021
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: 09/29/2021 Patient Sequence Number: 1
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