• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Nerve Damage (1979); Skin Irritation (2076)
Event Type  Injury  
Manufacturer Narrative
Pt identifier: unknown. Ages 3-17 years. Sex: 76 male and 42 female. Weight: unknown. Date of event: unknown. Implant date: unknown. Explant date: unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter phone number is unknown without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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: pogorelic, z. Et al. (2017) flexible intramedullary nailing for treatment of proximal humeral and humeral shaft fractures in children: a retrospective series of 118 cases. Orthopaedics and traumatology: surgery and research. Volume 103, pages 765-770. (croatia) this retrospective study aims to investigate the clinical and radiological outcome of humeral shaft and proximal humeral fractures treated by flexible intramedullary nailing (fin) in children. From may 2002 until may 2016, 118 patients (76 male and 42 female ages 3-17 years) were treated with two unknown synthes titanium intramedullary nails under general anesthesia once reduction was achieved. Follow up examination after a mean of 77 (3-176) months. Complications were reported as follows: one intraoperative fracture of humeral shaft in patient with osteogenesis imperfecta. Two patients had neurapraxia involving the radial nerve, which resolved after several weeks with no long-term complication. Four patients had entry site skin irritations which resolved without long-term effects and did not affect the results of the treatment. Skin infections at the entry site were noted in two patients. This report is for an unknown synthes titanium elastic nail. This is report 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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7469268
MDR Text Key106845796
Report Number8030965-2018-53413
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeHR
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 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
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 Received04/20/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/27/2018 Patient Sequence Number: 1
-
-