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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.9MM TI LOCKING BOLT 40MM ROD, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 4.9MM TI LOCKING BOLT 40MM ROD, FIXATION, BONE Back to Search Results
Catalog Number 459.400
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Date of event reported as 2018, exact date is not known. Additional product codes: hty, jdw, jds, jdn. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 patient was implanted with a proximal femoral nail antirotation (pfna) nail and two (2) bolts on (b)(6) 2018. On unknown date it was revealed that the nail and two (2) bolts were broken. This report is for one (1) locking bolt. This is report 3 of 3 for (b)(4).
 
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Brand Name4.9MM TI LOCKING BOLT 40MM
Type of DeviceROD, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SALZBURG
vorgartenstrasse 206b
wien CO 1020
AU 1020
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8141651
MDR Text Key129597559
Report Number8030965-2018-58824
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K970733
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number459.400
Device Lot Number5941049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2016
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: 12/07/2018 Patient Sequence Number: 1
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