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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: 3.5MM LCP MEDIAL DISTAL TIBIA PLATE PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: 3.5MM LCP MEDIAL DISTAL TIBIA PLATE PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown 3. 5 mm lcp medial distal tibia plate/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. 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: yorukoglu, a. C. , demirkan, a. F. , buker, n. (2018), distal medial tibial locking plate for fixation of extraarticular distal humeral fractures; an alternative choice for fixation, acta orthopaedica et traumatologica turcica, vol. 52 (issue 4), pages 294-298 (turkey). The aim of this (b)(6) study is to describe an alternative fixation method for distal humeral extra articular fractures through posterior approach using medial tibia anatomic locking plate; and evaluates the patient's functional outcome and union condition. Between 2011 to 2016, a total of 18 patients (11 male and 7 female) with an average age of 37. 0 ± 17. 3 years (range: 18-73 years) were included in the study. Surgery was performed using a distal tibia medial anatomic plate of 3. 5 mm (synthes) were used with minimum 6 screws distal and proximal to fracture. The mean follow-up was 36. 2 ± 16. 7 (12-57) months. The following complications were reported as follows: 1 patient had non-union due to infection and underwent debridement and the implant was (medial lateral plate) replaced. The continuity of the nerve was impaired in only 1 of patients with radial nerve injury. It was repaired with sural nerve graft. Vas pain score at rest has a maximum score of 7. 60. Vas pain score during activity has a maximum score of 9. This report is for an unknown synthes 3. 5 mm lcp medial distal tibia plate. This is report 1 of 2 for complaint (b)(4). It captures the adverse events of non-union due to infection and continuity of the nerve was impaired. A copy of the literature article is being submitted with this medwatch.
 
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Brand NameUNK - PLATES: 3.5MM LCP MEDIAL DISTAL TIBIA PLATE
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 Key9167036
MDR Text Key161787970
Report Number8030965-2019-69147
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeTU
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 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
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 Received09/18/2019
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: 10/08/2019 Patient Sequence Number: 1
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