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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/6 HOLE/159MM/RIGHT PLATE,FIXATION,BONE

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SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT PLATE,FIXATION,BONE Back to Search Results
Model Number 02.124.406
Device Problem Break
Event Type  Injury  
Manufacturer Narrative

(b)(6). Date of postoperative plate breakage is unknown. Additional device product codes: jdp, hwc. (therapy date): original surgery date (b)(6) 2017; exact date is unknown. Complainant device is not expected to be returned for manufacturer review/investigation. A device history record (dhr) review was performed for part # 02. 124. 406, lot # l343153: manufacturing location: (b)(4), manufacturing date: 24. Mar. 2017: no non-conformance reports (ncrs) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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

It was reported that the patient had original surgery in (b)(6) 2017 for treatment of a right distal femur fracture. Patient was implanted with one (1) 4. 5mm(va) variable angle locking compression curved condylar plate and eight (8) screws. Of the eight screws, one (1) 4. 5mm cortex screw was implanted at the shaft on the plate, and seven (7) 5. 0mm va locking screws were implanted in other plate hole screw positions. On an unknown date, post-operative, patient presented with a broken plate and one broken 4. 5mm cortex screw. The plate was broken at the broken cortex screw position. On (b)(6) 2017, surgeon removed all implants and revised the patient to a longer va locking plate and screws. It was reported that all screws, the plate and any fragments were retrieved. All implants have been retained by the hospital. Revision surgery was completed successfully with no time delay. Patient is reported in stable condition. Concomitant devices reported:5. 0mm va locking screws (part # unknown, lot # unknown, quantity 7) this report is for one (1) 4. 5mm va-lcp curved condylar plate/6 hole/159mm/right this is report 1 of 2 for complaint (b)(4).

 
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Brand Name4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT
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 Key6915222
Report Number1000562954-2017-10226
Device Sequence Number1
Product CodeHRS
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number02.124.406
Device Catalogue Number02.124.406
Device LOT NumberL343153
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 Received09/18/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/24/2017
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: 10/05/2017 Patient Sequence Number: 1
Treatment
SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 7)
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