• 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 ROD, FIXATION, INTRAMEDULLARY

  • 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 ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Brand name, common device name, lot #, part #, udi #, 510k: this report is for an unknown nail head elem: tfna hel/unknown lot. Part and lot number are unknown; udi number is unknown. Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation. Device evaluated by mfr: the investigation could not be completed; no conclusion could be drawn. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient had an open reduction internal fixation (orif) surgery for the left femoral trochanteric fracture using with trochanteric femoral nail advanced (tfna) in question. The surgery was completed without delay. However, on (b)(6) 2019, the hospital found an excessive sliding of an implant and patient started to have a follow-up. Eventually, the trochanteric femoral nail advanced blade implant cut-out was confirmed on (b)(6) 2019. Unfortunately, the patient got pneumonia and cannot undergo a re-operation. The hospital plans either removal surgery or bipolar hip arthroplasty after the patient recovers from the pneumonia. Patient outcome is unknown. Concomitant devices reported: unknown tfna nail (part# unknown, lot# unknown, quantity 1) and unknown locking screw (part# unknown, lot# unknown, quantity unknown). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 Key8405132
MDR Text Key138280430
Report Number8030965-2019-61835
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received04/15/2019
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: 03/08/2019 Patient Sequence Number: 1
-
-