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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES ELMIRA 1.5MM LCP ADAPTION PLATE 12 HOLE WITH GUIDES PLATE,FIXATION,BONE

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SYNTHES ELMIRA 1.5MM LCP ADAPTION PLATE 12 HOLE WITH GUIDES PLATE,FIXATION,BONE Back to Search Results
Catalog Number VP4102.12
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Product development investigation was completed. The report indicates that the: a 1. 5mm lcp adaption plate (vp4102. 12 lot unknown) bent. The returned device/plate was examined and both the complaint condition and x-ray imaging was able to be confirmed as the plate was found to be bend between the fourth and fifth hole. The complaint condition was unable to be replicated as due to post-manufacturing damage. Relevant drawings for the returned implant were reviewed (current revision as date of manufacturer is unknown) no definitive root cause was able to be determined with the provided information. This failure mode is typically associated with early weight bearing/patient non-compliance. A visual inspection, x-ray review, drawing review and device history review were performed as part of this investigation. The complaint condition was unable to be replicated as due to post-manufacturing damage. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition additionally the following concomitant screws were returned: vs101. 008 qty 5, vs101. 009 qty 4, vs101. 007 qty 1, vs101. 010 qty 1. The screws were examined and were found to be in good condition with minor signs of wear which can be associated with implantation and explantation. As there was no device allegation and no defects or deficiencies were identified, no further investigation will be completed. Device 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.
 
Manufacturer Narrative
510k #: device is a veterinary product. No patient information will be reported. (b)(4), lot number unknown. (therapy date): unknown. Without a lot number, the device history record review could not be requested. The device has been received and the product evaluation is in progress. No conclusion can be drawn. 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 used in a veterinary case. It was reported that a small dog had a plate that was twisted in the leg. It is unknown which leg the plate was implanted in. The surgeon had noticed that the plate was bent beforehand, this was not a revision surgery. Concomitant devices reported: cortex screws: (part # vs101. 008, lot # unknown, quantity 5, part # vs101. 009, lot # unknown, quantity 4, part # vs101. 010, lot # unknown, quantity 1, part # vs101. 007, lot # unknown, quantity 1). This report is for one (1) 1. 5mm lcp adaption plate. (b)(4).
 
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Brand Name1.5MM LCP ADAPTION PLATE 12 HOLE WITH GUIDES
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 Key6880508
MDR Text Key252104042
Report Number3003506883-2017-10211
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVP4102.12
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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