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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Between march 2008 and april 2015, a total of 33 patients (19 males and 14 females) with a mean age of 54. 64±18. 94 were treated with a pfna device (synthes, oberdorf, switzerland). This report is for an unknown pfna blade/unknown lot. Part and lot number 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. 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: imerci, a. , aydogan, n. , and yosun, k. (2018), a comparison of the intertan nail and proximal femoral fail antirotation in the treatment of reverse intertrochanteric femoral fractures, acta orthopaedica belgica, vol. 84, pages 123-131 (turkey). The aim of this study was to compare the clinical and radiological results of intertan nail and proximal femoral nail antirotation (pfna) in the treatment of reverse intertrochanteric fractures where the lateral cortex was fractured. Between march 2008 and april 2015, a total of 33 patients (19 males and 14 females) with a mean age of 54. 64±18. 94 were treated with a pfna device (synthes, oberdorf, switzerland). The minimum follow-up was 1 year. The following complications were reported as follows: patients needed a second surgery because of mechanical failure: 1 patient had an erosion developed in the acetabulum because of blade protrusion and total hip arthroplasty was applied. (cut through). This report is for an unknown pfna blade. This is report 9 of 9 for (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: PFNA BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key9535299
MDR Text Key188479537
Report Number8030965-2019-71555
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
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 Received12/17/2019
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: 12/31/2019 Patient Sequence Number: 1
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