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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM LCP PLATE 12 HOLES/108MM PLATE, FIXATION ,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM LCP PLATE 12 HOLES/108MM PLATE, FIXATION ,BONE Back to Search Results
Catalog Number VP4031.12
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: 510k#: device is a veterinary product. No patient information will be reported. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the dog was operated for a femoral fracture. On october 3, 2020 a complete relief of the affected extremity was observed by the owners. The dog was under permanent observation so a trauma can be excluded. X-rays taken on october 3, 2020 show an implant fracture and a high-grade dislocation of the fractured bone ends. A revision was performed on (b)(6) 2020. Concomitant device: unknown screw (part# unknown, lot# unknown, quantity unknown). This report is for one (1) 2. 7mm lcp plate 12 holes/108mm. This is report 1 of 1 for (b)(4).
 
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Brand Name2.7MM LCP PLATE 12 HOLES/108MM
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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10785081
MDR Text Key214642425
Report Number8030965-2020-08549
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVP4031.12
Device Lot Number57P7348
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2020
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: 11/04/2020 Patient Sequence Number: 1
Treatment
UNK - SCREWS: TRAUMA
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