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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM LCP ULNA OSTEOTOMY PLATE 8 HOLES PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM LCP ULNA OSTEOTOMY PLATE 8 HOLES PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.111.901
Device Problem Break (1069)
Patient Problems Non-union Bone Fracture (2369); Osteolysis (2377); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional pro-code: hwc. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. The investigation could not be completed; no conclusion could be drawn. 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, it was confirmed through x-ray and ct that the lcp ulna osteotomy plate was broken. It also shows probable nonunion with bone reabsorption along the majority of the osteotomy due to the broken plate. There was a very small amount of new bone bridging the osteotomy under the broken section of the plate. Initially, the patient had an ulna shortening procedure with two transverse cuts made with an unknown single saw blade (not parallel blades) that was compressed using an unknown compressor/distractor tool and fixed using locking compression plate (lcp) ulna osteotomy plate with six (6) unknown cortex screws and two (2) locking screws. Patient was asymptomatic and has no pain and has full function, so the surgeon decided not to revise at this time. Patient status is unknown. Concomitant devices reported: unknown locking screws (part# unknown, lot# unknown, quantity 2); unknown cortex screws (part# unknown, lot# unknown, quantity 4). This report is for one (1) 2. 7mm lcp ulna osteotomy plate 8 holes. This complaint involves two (2) devices. This report is 1 of 2 for (b)(4).
 
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Brand Name2.7MM LCP ULNA OSTEOTOMY PLATE 8 HOLES
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8438294
MDR Text Key139419304
Report Number8030965-2019-62106
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819414402
UDI-Public(01)07611819414402
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K113364
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 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.111.901
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 Received04/30/2019
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: 03/20/2019 Patient Sequence Number: 1
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