• 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 - NAILS: FEMORAL 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 UNK - NAILS: FEMORAL ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Sepsis (2067)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - nails: femoral/unknown lot. Part and lot numbers are unknown; udi 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 as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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: alobaidi a, et al. (2016), early and late intramedullary nailing of femur fracture: a single center experience, international journal of critical illness & injury science, volume 6, number 3, pages 143-147, (qatar). This retrospective study aims to describe the reamed intramedullary nailing (rimn) timing and hospital outcomes in trauma patients presenting with a femur fracture. Between january 2010 and january 2012, 307 patients who sustained trauma with single or bilateral femur fracture (shaft) and underwent intramedullary nailing (piriformis entry and close nailing) were included in the study. Patients were divided into two groups: group 1 (early); those whose femur fractures were treated with primary rimn at less than 12 hours of injury and group 2 (late); those whose femur fractures were treated at 12 hours or more. Group 1 included 156 patients with a mean age of 29+/-9 years, 149 of them were males. Group 2 included 151 patients with a mean age of 36 +/-18 years, 137 of them were males. These patients were implanted with either an unknown ao intramedullary nail or a competitor¿s device. Complications were reported as follows: (group 1: early treatment). 4 patients had systolic blood pressure lower than 90mmhg. 54 patients had systemic inflammatory response syndrome. 3 patients had wound infection. 1 patient had sepsis. 1 patient had a fat embolism. 1 patient had an adult respiratory distress syndrome. 1 patient died. This patient had an isolated femur fracture complicated with fat embolism and adult respiratory distress syndrome. (group 2: late treatment). 5 patients had systolic blood pressure lower than 90 mmhg. 54 patients had systemic inflammatory response syndrome. 1 patient had bedsore. 8 patients had wound infection. 2 patients had sepsis. 1 patient had a fat embolism. 2 patients had an adult respiratory distress syndrome. This report is for the unknown ao intramedullary nail. This is report 01 of 01 of (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - NAILS: FEMORAL
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 19380
6103142063
MDR Report Key9757585
MDR Text Key189321422
Report Number8030965-2020-01447
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2020
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 Received02/05/2020
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: 02/26/2020 Patient Sequence Number: 1
-
-