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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 LAT DSTL HUM PL 1H/RT/69MM SHRT-STER PLATE FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM TI VA-LCP LAT DSTL HUM PL 1H/RT/69MM SHRT-STER PLATE FIXATION, BONE Back to Search Results
Catalog Number 04.117.801S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2020
Event Type  malfunction  
Manufacturer Narrative
Additional device product code: hwc. The device has been 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 by using 2. 7 mm va lcp elbow system. During the surgery, when the surgeon tried to fix the plate with the locking screw, but he could not tighten the locking screw while it turned idle. He changed inserting angle of the locking screw and tried to insert it, but he could not tighten it. He removed the plate and checked whether the locking screw could be tightened or not, but the locking screw could not be tightened. Surgeon used another plate and the locking screw,to complete the procedure. The surgery was successfully completed with a sixty (60) minute surgical delay. Patient outcome is reported as stable. No further information is available. Concomitant device reported: va lockscr ø2. 7 head 2. 4 self-tap l30 ta (part # 04. 211. 030s, lot # 1l77561, quantity 1). This report is for one (1) 2. 7mm/3. 5mm ti va-lcp lat dstl hum pl 1h/rt/69mm shrt-ster. This is report 1 of 2 for (b)(4).
 
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Brand Name2.7MM/3.5MM TI VA-LCP LAT DSTL HUM PL 1H/RT/69MM SHRT-STER
Type of DevicePLATE FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10548066
MDR Text Key207404424
Report Number8030965-2020-07158
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 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.117.801S
Device Lot NumberH700967
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
Treatment
VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L30 TA
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