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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 2H/LT/85MM-MED-STER PLATE,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 2H/LT/85MM-MED-STER PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.117.702S
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2020
Event Type  malfunction  
Manufacturer Narrative
Additional procode: hwc. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation (orif) surgery for distal humeral fractures with the plate in question. During the surgery, the surgeon tried to fit the plate onto the bone in order to fix the distal humeral end, but the plate did not fit the bone. He tried to bend the plate about three times while applying it to the bone. When he was checking the position of placement of the plate, he noticed that the plate had been broken. There was no sound or noise to be heard during bending. As the screw hole of the plate was broken, he used another plate to continue the surgery. The surgery was successfully completed with a less-than-30-minute delay. No further information is available. This report is for one (1) 2. 7mm/3. 5mm ti va-lcp ext medl dhp 2h/lt/85mm-med-ster. This is report 1 of 1 for (b)(4).
 
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Brand Name2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 2H/LT/85MM-MED-STER
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10382284
MDR Text Key203835952
Report Number8030965-2020-05775
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.117.702S
Device Lot Number6L17118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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