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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown locking compression plates (lcp)/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.
 
Event Description
This report is being filed after the review of the following journal article: shou k. , et al (2020) the assessment of the reduction algorithm in the treatment for ¿logsplitter¿ injury, biomed research international volume xxxxxx,pages 1-8, (china). This retrospective cohort study aims to focus on the intraoperative reduction quality and evaluated some key parameters to help orthopedic surgeons achieve better functional outcomes with "logsplitter " injury in the future. From january 2015 to february 2019 , a total of 31 patients (19 male and 12 female) mean age 37:6 ± 9:4 (21¿59) years were enrolled in this study. Distal fibular fractures were fixed by using the lcp plates and the medial malleolus fracture was fixed using two cannulated screws or the kirschner wire. One or two syndesmotic screws were used to fix the syndesmosis joint. Patients were followed up for the wound, bone union, range of motion, ankle joint function, and postoperative traumatic arthritis at postoperative 3 months, 6 months, 12 months, and 2 years. Mean follow-up was 22:9 ± 3:3 (13¿26) months. Mean follow-up was 22:9 ± 3:3 (13¿26) months. The following complications were reported as follows: 14 of 31 patients were observed of radiographic posttraumatic arthritis of the ankle joint. 8 poor reduction occurred at 24 months final follow-up. A case of a (b)(6) year old man who suffered from falling from a height, showing the malreduction of the lower tibiofibular joint revised surgery to obtain acceptable anatomy of tfol and tfcs. However, gradual degeneration of the tibiotalar joint and deterioration of the joint surface were observed. Significant posttraumatic osteoarthritis occurred at the ankle joint at the last follow-up (the typical case with unfavorable intraoperative reduction was shown in). This report is for an unknown synthes locking compression plate (lcp). It captures a case of a (b)(6) year old man who suffered from falling from a height, showing the malreduction of the lower tibiofibular joint revised surgery to obtain acceptable anatomy of tfol and tfcs. However, gradual degeneration of the tibiotalar joint and deterioration of the joint surface were observed. Significant posttraumatic osteoarthritis occurred. This is report 2 of 2 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
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 Key10687376
MDR Text Key214124246
Report Number8030965-2020-07973
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
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 Received09/24/2020
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: 10/15/2020 Patient Sequence Number: 1
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