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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 Problem Injury (2348)
Event Date 07/11/2020
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown locking compression plate (lcp) construct/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.
 
Event Description
This report is being filed after the review of the following journal article: yuan, y. Et al. (2020), clinical outcomes of revision with retrograde intermedullary nailing for failed plating of distal femoral fractures: a retrospective study, international orthopaedics, vol. Xx, pages 1-6 (china). The purpose of this study is to assess the feasibility and effectiveness of retrograde intramedullary nail (rin revision surgeries for locking compression plate (lcp) failure in distal femoral fractures. Between january 2014 and december 2016, patients with distal femoral fractures underwent open reduction and locking compression plate (lcp) fixation. 13 patients (11 males and 2 females; ranged in age from 22 to 63 years old, with a mean age of 45. 6 ± 4. 0 years) suffering from metalwork failures after initially undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures eventually underwent rin. The average duration from lcp fixation to metalwork failure was one¿18 months (mean, 8. 0 ± 5. 5 months). The following complications were reported as follows: patient 1: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 2: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 3: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 4: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 5: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 6: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 7: a (b)(6) year old female patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 8: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 9: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 10: a (b)(6) year old female patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 11: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 12: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. Patient 13:: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures. This report is for an unknown synthes locking compression plate (lcp) construct. It captures the reported (b)(6) year old female patient who had a metalwork failure. This is report 10 of 10 for (b)(4). Additional devices are reported under related complaint (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 Key10538334
MDR Text Key207759397
Report Number8030965-2020-07010
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 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2020
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 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: 09/15/2020 Patient Sequence Number: 1
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