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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); Joint Dislocation (2374)
Event Type  Injury  
Manufacturer Narrative
There are multiple patients all information is provided in the article. 510k: this report is for an unknown tomofix osteotomy plate/unknown lot. Part and lot number are unknown; udi number is unknown. Implant date is between 2013 and 2016. 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: otsuki s, et al (2018), risk of patella baja after opening-wedge high tibial osteotomy, journal of orthopaedic surgery, volume 26 (3), page 1-6, (japan) the purpose of this study was to measure preoperative and postoperative patellar height and to determine the correlation between the opening-wedge high tibial osteotomy correction angle and patellar height based on the caton¿deschamps index. Between 2013 and 2016, 75 knees (from 32 men and 43 women) that underwent opening-wedge high tibial osteotomy were included in the study. The mean patient age was 63. 1+/-11. 4 years (range, 44¿78), and the mean body mass index was 24. 5 +/- 2. 9 kg/m2 (range 20. 8¿35. 9). Osteotomy fixation was performed using an unknown synthes tomofix osteotomy plate or a competitor¿s device. The gap created by the opening-wedge high tibial osteotomy was filled using a competitor¿s b-tricalcium phosphate. Rehabilitation was initiated on postoperative day 1 with 50 percent weight-bearing allowed initially and full weight-bearing permitted on day 14. Postoperative measurements were performed at the final follow-up, which occurred at an average of 24. 8 months (range 18¿ 42 months). Complications were reported as follows: 18 knees exhibited patella baja (caton¿deschamps index lesser than 0. 6) after opening-wedge high tibial osteotomy. This report is for the unknown synthes tomofix osteotomy plate and unknown synthes screw. A copy of the literature article is being submitted with this medwatch. This report is for one (1) unknown tomofix osteotomy plate 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10547469
MDR Text Key207496583
Report Number8030965-2020-07154
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 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
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 Received08/24/2020
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: 09/17/2020 Patient Sequence Number: 1
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