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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES ELMIRA 2.0MM/1.5MM LCP PLATE 14 HOLES/97MM-1.5MM THK PLATE,FIXATION,BONE

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SYNTHES ELMIRA 2.0MM/1.5MM LCP PLATE 14 HOLES/97MM-1.5MM THK PLATE,FIXATION,BONE Back to Search Results
Catalog Number VP4012.14
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device used in a veterinary case - no patient information will be reported. Date of postoperative plate bending is unknown. (b)(4). Lot number unknown. Date of original implant is unknown. Complainant device is not expected to be returned for manufacturer. Review/investigation. Therapy date is unknown. Reporter phone number is unknown. As device is veterinary product. A 510k number is not available. 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. 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
This report is for a veterinary case. There was no human patient involvement. It was reported that a 14 hole 2. 4 mm locking compression plate (lcp) that was implanted to treat a tibia fracture in a feline patient bent post-operatively on an unknown date. Date of original intramedullary fixation surgery is unknown. On (b)(6) 2017, the feline patient was revised to an unknown angle stable nail (i-loc 4x118 mm) in a 2-2 static configuration. The surgery was completed successfully the feline patient is in stable condition. Concomitant devices reported: locking head screws (part # unknown, lot # unknown, quantity 6). This report is for one (1) 2. 0mm/1. 5mm lcp plate. This is report 1 of 1 for complaint (b)(4).
 
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Brand Name2.0MM/1.5MM LCP PLATE 14 HOLES/97MM-1.5MM THK
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer (Section G)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6808293
MDR Text Key83749991
Report Number3003506883-2017-10178
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVP4012.14
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2017
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

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