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Adverse Event Report

CODMAN & SHURTLEFF, INC. MEDOS S.A. UNKNOWN CODMAN ACP CANCELLOUS BONE SCREW APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY   back to search results
Event Date 06/07/2000
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Pt's attorney reports in 2000, plaintiff underwent an anterior cervical discectomy at c6-7 with arradial iliac crest graph and internal fixation performed. On or about 6/2000, the screws and locking plates used in the anterior cervical discectomy broke while pt's neck was being physically manipulated at rehabilitation facility. Subsequent x-rays of the pt's spine revealed that two screws at the c7 level fractured causing one of the plates to migrate rostrally. Pt is reported to have developed chronic neck pain, mechanical neck pain, and other injuries.

 
Manufacturer Narrative

See h10.

 
Manufacturer Narrative

Codman has requested the device be returned for eval. Follow up report will be filed with the fda if/when the device is returned and evaluated or if it is determined that the device is not available for eval.

 
Manufacturer Narrative

The device was not returned for eval. A review of the device history record cannot be performed as the device catalog# and serial# are unknown. The complaint is considered to be closed at this time. It will be reopened when/if the device is returned for eval and/or the device catalog and serial numbers are made available.

 
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Brand NameUNKNOWN CODMAN ACP CANCELLOUS BONE SCREW
Type of DeviceAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CODMAN & SHURTLEFF, INC. MEDOS S.A.
rue girardet 29
le locle
SWITZERLAND CH-2400
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. MEDOS S.A.
rue girardet 29
le locle
SWITZERLAND CH-2400
Manufacturer Contact
matthew king
325 paramount dr
raynham , MA 02767
(508) 828 -3106
Device Event Key397805
MDR Report Key408810
Event Key386466
Report Number1226348-2002-00142
Device Sequence Number1
Product CodeKWQ
Report Source Manufacturer
Source Type Other
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 07/08/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/08/2002
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/20/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
1,UNKNOWN CODMAN ACP CANCELLOUS BONE SCREW, MFG,
2,MEDWATCH REPORT# 1226348-2002-0143,,
3,CODMAN REF# 0200772C-2.,

Database last updated on January 30, 2009

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