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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown titanium elastic nail/unknown lot. Part and lot numbers are unknown; udi numbers are unknown. Implantation and explantation dates are 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. 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: verma a. Et al. (2017). Clinical outcome of treatment of diaphyseal fractures of humerus treated by titanium elastic nails in adult age group. Journal of clinical and diagnostic research. Volume 11, number 5, pages 01-04. (india). This prospective study was done to assess the clinical outcome of treatment of diaphyseal fractures of the humerus treated with titanium elastic nails (ten) under closed reduction and internal fixation surgery. This study involved 20 patients (17 males and 3 females) with the age group 18-60 years (mean age 38 years); all were admitted between october 2014 and september 2015. Post-operative follow-ups were done at 1 week, 3 weeks, 3 months and 6 months. There were nine complications observed. Complications were reported as follows: two cases presented superficial infection near the entry site. Four cases had nonunion; all of them having spiral and oblique fracture patterns; for which re-surgery was done for implant removal and open reduction internal fixation with dynamic compression plating along with bone graft. Two cases of elbow stiffness were observed. One case of implant failure was observed post-surgery. This report is for an unknown synthes titanium elastic nail (ten). This report is 2 of 2 for (b)(4). A copy of the literature article is being submitted with this medwatch.
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7510300
MDR Text Key108233042
Report Number8030965-2018-53727
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
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 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
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 Received04/23/2018
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: 05/14/2018 Patient Sequence Number: 1
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