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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CAGE 12MM X 20MM VU-MESH

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INTEGRA LIFESCIENCES CORPORATION OH/USA CAGE 12MM X 20MM VU-MESH Back to Search Results
Catalog Number 15-10-1220
Device Problems Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)
Patient Problem Paralysis (1997)
Event Date 07/09/2014
Event Type  Injury  
Event Description

Letter was receive via (b)(6) from competitor company, it was reported "surgical outcome resulted in a paralysis following anterior cervical discectomy and fusion (acdf) with aviator plate and screws. (competitor's device) and integra-stackable peek device. It appears the integra corpectomy device retropulsed resulting in loss of signals as noted by biotronics".

 
Manufacturer Narrative

The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.

 
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Brand NameCAGE 12MM X 20MM
Type of DeviceVU-MESH
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
cincinnati OH 45227
Manufacturer Contact
caren finkelstein
315 enterprise drive
plainsboro, NJ 08536
6099362341
MDR Report Key4060331
MDR Text Key16178238
Report Number3004608878-2014-00147
Device Sequence Number1
Product Code MQP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK070381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/30/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number15-10-1220
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received07/30/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/25/2014 Patient Sequence Number: 1
Treatment
15-12-1225 END CAP 12MM; 15-12-1200 END CAP 12MM; 2.5 DEG
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