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Adverse Event Report

CODMAN & SHURTLEFF, INC. CODMAN "CLASSIC" KOCKER   back to search results
Model Number 34-4110
Event Description

Pt was undergoing spinal surgery in 2003, and as the surgeon was using the codman kocker, its tip broke off (one of the two grasping prongs, measuring 1-3/4-inches in length, broke off). All pieces of the device were retrieved. The pt was not affected in any way, and the surgery was not extended in length.

 
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Brand NameCODMAN "CLASSIC"
Type of DeviceKOCKER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Device Event Key446589
MDR Report Key457604
Event Key433477
Report NumberMW1028307
Device Sequence Number1
Product CodeHBF
Report Source Voluntary
Report Date 04/24/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number34-4110
OTHER Device ID Number"CLASSIC"
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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