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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This patient¿s information is not available. Date of postoperative necrosis development is unknown. This report is for an unknown tfna nail/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (510k): unknown, as specific part and lot numbers for tfna nail is not provided. (b)(4). 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.
 
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017 a patient underwent for the surgery to treat the subtrochanteric fracture and was implanted with trochanteric femoral nail-antirotation (tfna) system. On an unknown postoperative date, the patient visited the hospital because patient felt a pain. It was found under the x-ray that necrosis of the femoral head had occurred while the bone union was observed. On (b)(6) 2018, the revision surgery is scheduled to extract the tfna implants and apply the bipolar hip arthroplasty (bha). The surgeon does not know what caused this event because the patient had not taken any special medications. Concomitant devices reported: nail head elements: screw (part # unknown, lot # unknown, quantity 1), end caps: tfna (part # unknown, lot # unknown, quantity 1). This report is for one (1) unknown tfna nail. This is report 1 of 2 for complaint (b)(4).
 
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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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7636342
MDR Text Key112276115
Report Number8030965-2018-54610
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
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
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 Received05/31/2018
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: 06/25/2018 Patient Sequence Number: 1
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