• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Nerve Damage (1979); Loss of Range of Motion (2032); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown lcp plate and screw construct/unknown lot. Part and lot number are unknown; udi number is unknown. Date of implantation is an unknown date between (b)(6) 2013 and (b)(6) 2014. 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: meluzinova p, et al (2015), plate osteosynthesis of distal ulna fractures with associated distal radius fractures treated by open reduction and internal fixation. Short-term functional and radiographic results, acta chirurgiae orthopaedicae et traumatologiae cechosl, volume 82, pages 369-376, (czech republic). The aim of the study was to describe the indication criteria and operative technique and to present the first conclusions of a prospective study dealing with an assessment of functional and radiographic findings in patients with concurrent fractures of the distal ulna and distal radius; the former was treated by osteosynthesis using a locking compression plate (lcp) distal ulna plate (de puy synthes, usa) and the latter by plate osteosynthesis. Between august 2013 and september 2014, 18 patients (3 men and 15 women; average age, 58 years; range, 25-74 years) with a fracture of the distal ulna and a concurrent distal radius fracture treated by plate osteosynthesis were included in the study. All patients were treated with an unknown synthes locking compression plate distal ulna plate for the distal ulnar fractures and an unknown synthes variable angle-locking compression plate for the distal radius fractures. The average follow-up was 9 months, with 13 patients being followed up for 6 months at least. Complications were reported as follows: 1 patient had an early repeated surgery due to incongruence of the articular surface of the radiocarpal joint as the result of an inadequately repositioned radial pillar. 2 patients had an early repeated surgery due to the incorrect positioning of a screw in the radiocarpal joint. 5 patients had post-operative irritation of the r. Dorsalis n. Ulnaris and soft tissues in the area of the distal part of the ulnar plate which made it necessary to remove the implant from 3 patients. 1 patient developed symptoms of mild carpal tunnel syndrome, although the patient refused the recommended deliberation of the n. Medianus. This report is for the unknown synthes locking compression plate distal ulna plate, unknown synthes variable angle-locking compression plate and unknown synthes screws. This is report 1 of 3 for pc-(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9621279
MDR Text Key189993070
Report Number8030965-2020-00555
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeEZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2020
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 Received01/23/2020
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: 01/23/2020 Patient Sequence Number: 1
-
-