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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PADDLE SHAVER

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NUVASIVE, INC. NUVASIVE PADDLE SHAVER Back to Search Results
Catalog Number 7174007
Device Problem Break
Event Type  Other  
Event Description

During disc clearance, the paddle shaver reportedly snapped and was left in the disc space. The surgeon tried to retrieve the paddle portion of the instrument but was unable. The tlif procedure was abandoned and the pt underwent an alif revision to remove the tip and correct the initial pathology.

 
Manufacturer Narrative

(b)(4). Neither the instrument tip nor handle has been returned for investigation. The root cause of the reported event is unk at this time. Labeling review notes the following: "the physician should take precautions against putting undue stress on the spinal are with instruments. Any surgical technique should be carefully followed. Breakage of the device, which could make necessary removal difficult or sometimes impossible, with possible consequences of late infection and migration. Breakage could cause injury to the pt pain, discomfort, or abnormal sensations resulting from the presence of the device. ".

 
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Brand NameNUVASIVE PADDLE SHAVER
Type of DevicePADDLE SHAVER
Manufacturer (Section D)
NUVASIVE, INC.
san diego CA
Manufacturer Contact
paul holbrook
7475 lusk blvd.
san diego , CA 92121
8583205285
MDR Report Key2748686
Report Number2031966-2012-00039
Device Sequence Number1
Product CodeLXH
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/04/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number7174007
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/03/2012
Event Location Hospital
Date Manufacturer Received08/06/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/07/2012 Patient Sequence Number: 1
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