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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); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown fixed-angle plate (tomofix)/ unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. (b)(4). 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. (b)(4).
 
Event Description
This report is being filed after the review of the following journal article: lee s. , et al (2019) predictive factors for patellofemoral degenerative progression after opening-wedge high tibial osteotomy,the journal of arthroscopic and related surgery, vol 35, no 6, pp 1703-1710, (korea, south), https://doi. Org/10. 1016/j. Arthro. 2019. 01. 032. This study aims to identify risk factors for patellofemoral degenerative progression after opening-wedge hto and to investigate the effect of patellofemoral degeneration on the patellofemoral specific patient-reported outcomes. From march 2010 to june 2016,a total of 135 cases (123 patients) who were clinically followed up underwent opening-wedge hto. 94 cases (86 patients) (26 males, 68 females) age 51. 7 - 9. 1 (21-64) years were included in this study. Biplanar osteotomy was performed in all knees, and the osteotomy was stabilized using a fixed-angle plate with interlocking screw (tomofix, synthes, solothurn, switzerland). Hardware removal was performed at least 18 months later after index surgery; the mean time from index surgery to hardware removal was 21. 4 months (18-55 months). The mean follow-up period was 49 months (24-90 months). The following complications were reported as follows: fig 1. Degenerative progression in the patellofemoral joint (all figures are right-sided knee). (a) intact trochlea cartilage at index surgery and (b) grade 3 chondral lesion on second-look arthroscopy in the same patient are shown. Moreover, progression of degeneration of the patella cartilage (c) at index surgery (grade 0) and (d) on second-look arthroscopy (grade 2) is shown. Of the 94 knees included, 26 and 16 knees exhibited progression of chondral lesion on the trochlea and patella, respectively. Fourteen knees showed progression at both sides; therefore, 28 knees showed progression on either the trochlea or patella. Postoperative clinical outcomes were worse in the progression group. This report is for an unknown synthes fixed-angle plate (tomofix). 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 Key10468505
MDR Text Key204870043
Report Number8030965-2020-06460
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
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 Received08/05/2020
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: 08/28/2020 Patient Sequence Number: 1
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