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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Hematoma (1884); Unspecified Infection (1930); Necrosis (1971); No Code Available (3191)
Event Date 12/08/2013
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown plates/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: zwipp, h. Et al (2013), operative treatment of central talar fractures, operative orthopadie und traumatologie, vol. 25 (6), pages 554-568 (germany). The aim of this study is to provide an operative treatmentfor displaced intra-articular calcaneal fractures with restoration of height, length, and axial alignment and reconstruction of the subtalar and calcaneocuboid joints. Between (b)(6) 2000 to (b)(6) 2013, a total of 163 patients were included in the study. Surgery was performed using a non-angle-stable ao plate (sanders plate or "tampa plate") in 53 cases and an angle-stable ao plate in 63 cases, both made by the company synthes, (b)(4). The following complications were reported as follows: 22 patients had superficial wound edge necroses which healed secondarily with local wound care without any revision. 4 patients had postoperative hematoma which required surgical revision. 2 patients had superficial infection. In 9 patients, a secondary subtalar arthrodeses were performed due to painful posttraumatic arthroses in the subtalar joint. 5 patients had deep infection which required aggressive debridement with plate removal and changing to screws. 2 of these patients needed a free flap for definite wound coverage, no calcanectomy or amputation was needed. This report is for an unknown synthes plates. This is report 1 of 4 for complaint (b)(4). It captures adverse events of superficial wound edge necroses, postoperative hematoma which required surgical revision, superficial infection, painful posttraumatic arthroses in the subtalar joint. A copy of the literature article is being submitted with this medwatch.
 
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Brand NameUNK - PLATES
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 Key8967633
MDR Text Key161006144
Report Number8030965-2019-68008
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
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 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
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 Received08/08/2019
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: 09/05/2019 Patient Sequence Number: 1
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