Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 - PLATES; 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 - PLATES; PLATE,FIXATION,BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problems Skin Irritation (2076); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
Multiple patient involved in the study.Alert date corrected to 11/08/2019.Implantation date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.Product was not returned.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
Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: shim, j.I., et al.(2019), changes in ulnar variance after a triangular fibrocartilage complex tear, journal of wrist surgery, vol.1, pages 30-36, (south korea).The relationship between triangular fibrocartilage complex (tfcc) tear and ulnar impaction syndrome (uis) has not been fully understood.We hypothesized that a tfcc tear could change the ulnar variance, which may be the cause of ulnar impaction syndrome.Between january 2011 and june 2016, a total of 72 patients (42 males and 30 females) with a mean age of 34 years (range: 13-79 years) were included in this study.Among them, 44 patients diagnosed as tfcc foveal tear with the druj instability and no uis underwent tfcc foveal repair only (group a).In the first 12 patients, only tfcc repair was performed when the patient had tfcc foveal tear without positive physical examinations of uis.However, around one year after the surgery, 3 of the 12 patients newly complained of symptoms and signs of uis and eventually underwent revision surgery (ulnar shortening osteotomy).And 28 patients diagnosed as tfcc foveal tear with uis underwent tfcc foveal repair and ulnar shortening osteotomy simultaneously (group b).The patients who underwent ulnar shortening osteotomy using an lcp distal ulna plate (synthes gmbh).The following complications were reported as follows: a (b)(6) year-old male patient had increased ulnar variance, there was no significant improvement of range of motion, except for pronation¿supination motion.This report is for an lcp distal ulna plate (synthes gmbh).Author's additional notes: 2.0mm ulnar hook plate: first, the hooks are too prominent and sometimes they are irritating to the ecu tendon and skin.2nd proximal hole: found that the second proximal hole at the diaphyses cannot hold the locking guide very well and it is difficult to make a locking drill hole with it.This is report 3 of 3 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Complainant part is not expected to be returned for manufacturer review/investigation.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 is report 4 of 5 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNK - PLATES
Type of Device
PLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9446356
MDR Text Key185682520
Report Number8030965-2019-70993
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/11/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-