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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: TOMOFIX OSTEOTOMY PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: TOMOFIX OSTEOTOMY PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Non-union Bone Fracture (2369); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
There are multiple patients. All known information is provided in the literature article. This report is for unknown tomofix osteotomy plates/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. (b)(4). 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: goshima k, et al. (2019), large opening gaps, unstable hinge fractures, and osteotomy line below the safe zone cause delayed bone healing after open-wedge high tibial osteotomy, knee surgery, sports traumatology, arthroscopy, volume 27, page 1291-1298, (japan). The purposes of this study were (1) to clearly define the bone formation at the osteotomy site; (2) to evaluate the progression of bone formation at the osteotomy gap after open-wedge high tibial osteotomy, including after plate removal; and (3) to investigate risk factors for delayed bone healing. Between february 2007 and august 2015, 93 patients (102 knees) with osteoarthritis or osteonecrosis who underwent open-wedge high tibial osteotomy were included in the study. There were 29 males and 64 females with a mean age of 62. 62 years (range, 22-83 years). Their mean height was 158. 2 cm (range, 41-182. 3 cm), mean body weight was 61. 3 kg (range, 32. 9-92. 4 kg), and mean body mass index was 24. 3 kg/square meter (range, 16. 1-31. 3 square meter). An open-wedge high tibial osteotomy was performed, and the patients were implanted with an unknown synthes tomofix plate that was fixed in place with (8) unknown synthes locking screws. All patients had the plate removed at more than 1 year after surgery, and the mean interval from surgery to plate removal was 17. 6 +/- 5. 1 months (range, 12¿38 months). Bone formation in the osteotomy gap was evaluated at 3, 6, and 12 months postoperatively; at plate removal; and at the final follow-up (mean, 62. 3 +/- 30. 2 months). Complications were reported as follows: 10 patients had delayed union. 2 of the patients who had delayed union underwent revision surgery because of nonunion. 2 patients had a loss of correction. 6 patients had limitations of weight-bearing until a hinge union was needed. This report is for the unknown synthes tomofix plate and unknown synthes screws. This is report 1 of 2 for (b)(4).
 
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Brand NameUNK - PLATES: TOMOFIX OSTEOTOMY
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10521510
MDR Text Key215144035
Report Number8030965-2020-06840
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,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
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 Received08/14/2020
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: 09/11/2020 Patient Sequence Number: 1
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