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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PLATE, FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH PLATE, FIXATION,BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); No Code Available (3191)
Event Date 11/26/2018
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown plate femoral/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. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.
 
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient underwent an unknown surgery on (b)(6) 2018, due to a femoral trochanteric fracture on the same side of the leg. The patient initially had an implantation on (b)(6) 2012 with an unknown locking compression plate (lcp) distal femur plate due to a distal femur fracture. The fracture part has healed and it becomes an obstacle to do the re-operation procedure for a trochanteric fracture. The original plan of the surgery was to remove the lcp distal femur plate and implant a long nail. The trochanter was fixed with a short nail. There was a 40-minute surgical delay. Patient status and surgical outcome were unknown. This complaint is for (1) unk - plate femoral. Concomitant devices reported: unknown screws (part # unknown, lot # unknown, quantity of 9). This complaint involves two (2) device. This report is 1 of 2 for (b)(4).
 
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Type of DevicePLATE, FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8170748
MDR Text Key130541057
Report Number8030965-2018-59093
Device Sequence Number1
Product Code HRS
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,Followup,Followup,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
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 Received02/07/2019
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: 12/17/2018 Patient Sequence Number: 1
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