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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT PLATE,FIXATION,BONE

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SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT PLATE,FIXATION,BONE Back to Search Results
Catalog Number 02.124.411
Device Problem Break
Event Type  Injury  
Manufacturer Narrative

Device used for treatment, not diagnosis. Patient information not available for reporting. (b)(4). Device is not expected to be returned for manufacturer review/investigation. Concomitant devices reported: therapy date is unknown. Screws - mix of cortical and locking screws (quantity# 10 to 12). Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

It was reported that the patient underwent revision surgery due to a broken plate. The plate was originally implanted months earlier at another institution and consisted of a 4. 5 mm variable angle (va) locking compression plate (lcp) curved condylar plate/ 10 hole/ 230 mm/ left and ten (10) to twelve (12) screws (mix of cortical and locking screws). It was reported that the plate broke into two (2) clean pieces. The plate and all screws were removed and the patient was revised to a femoral nail. The surgery was reported to be successfully completed. Patient outcome is unknown since the hospital did not wish to share any patient information. This complaint involves one (1) device. Concomitant devices reported: screws - mix of cortical and locking screws (part# unknown, lot# unknown, quantity# 10 to 12). This report is 1 of 1 for (b)(4).

 
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Brand Name4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES MEZZOVICO
zona industriale 4
mezzovico CH680 5
SZ  CH6805
Manufacturer (Section G)
SYNTHES MEZZOVICO
zona industriale 4
mezzovico CH680 5
SZ  CH6805
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7020559
Report Number1000562954-2017-10246
Device Sequence Number1
Product CodeHRS
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number02.124.411
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 Received10/18/2017
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

Patient TREATMENT DATA
Date Received: 11/10/2017 Patient Sequence Number: 1
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