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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 Unspecified Infection (1930); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Multiple patient involved. Implantation date unknown. This report is for an unk - plates: tomofix osteotomy/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 as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. (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
Device report from korea, south reports an event as follows: this report is being filed after the review of the following journal article: moon hs, et al. (2019), the effect of cartilage lesion in the lateral compartment of the knee on the surgical outcome of medial open-wedge high tibial osteotomy, the journal of knee surgery, page 1-8, (south korea). The aim of this study was to identify the effect of cartilage lesion in the lateral compartment of the knee on the surgical outcome of the medial open-wedge high tibial osteotomy. Between january 2010 and december 2017, a total of 172 consecutive patients underwent medial open-wedge high tibial osteotomy. These patients were implanted with an unknown synthes tomofix plate. All patients were advised to remove the plate if radiographic evidence of bony consolidation in the osteotomy site was identified to avoid surgical site pain owing to local irritation of the plate. If the plate removal was scheduled, patients were recommended to undergo second-look arthroscopy at the same time. The patients who underwent second-look arthroscopic assessment were included in this study. Those with (1) a previous surgical history of the knee, (2) surgical site infection, (3) subsequent additional surgical procedure of the same knee during the follow-up period, and (4) subsequent same surgical procedure for the contralateral knee during the follow-up period were excluded. As a result, 94 patients were included in this study. These patients were divided into 2 groups. Group 1 consisted of 30 patients (11 males and 19 females, mean age of 55. 2+/-5. 0 years) with cartilage lesion in the lateral compartment of the knee. Group 2 consisted of 64 patients (15 males and 49 females, mean age 54. 6+/-4. 5 years) with normal or near-normal cartilage lesion in the lateral compartment of the knee. Postoperatively, after splint immobilization for 2 weeks, exercise for a range of motion was started with the knee protected by a hinged knee brace for an additional 4 weeks. Progressive crutch-assisted tolerable weight-bearing ambulation was encouraged immediately after the surgery. The mean time from medial open-wedge high tibial osteotomy to the second-look operation was 22. 3+/-6. 1 and 22. 9+/-5. 6 months for groups 1 and 2, respectively. Complications were reported as follows: 2 patients had a surgical site infection. 9 patients had subsequent additional surgery of the same knee during the follow-up period. 4 patients in group 1 showed deterioration of the lateral compartment of the knee. 9 patients in group 2 showed deterioration of the lateral compartment of the knee. This report is for the unknown synthes tomofix plate and unknown synthes locking screw. This is report 1 of 2 (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 Key10541901
MDR Text Key214362856
Report Number8030965-2020-07093
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
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 Received08/20/2020
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: 09/16/2020 Patient Sequence Number: 1
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