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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SPINOUS PROCESS PLATE SYSTEM SPINAL INTERLAMINAL FIXATION ORTHOSIS

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NUVASIVE, INC. NUVASIVE SPINOUS PROCESS PLATE SYSTEM SPINAL INTERLAMINAL FIXATION ORTHOSIS Back to Search Results
Model Number 7577035
Event Date 01/07/2013
Event Type  Injury  
Event Description

Initial surgery was performed (b)(6) 2012, involving a female patient who received two interlaminal fixation device (affix ii plates) in conjunction with two allografts spacers for fusion treatment at l3/4 and l4/5. The patient reportedly fell twice post-operatively due to weakness as a possible result of hospital-acquired infection. Patient failed to follow post operative care and proper grooming resulting in additional infections and osteolysis, unrelated to the device. Patient fractured her spinous process which required revision surgery on (b)(6) 2013.

 
Manufacturer Narrative

(b)(4). Revision surgery occurred on (b)(6) 2013 and the device was returned. Evaluation of the two devices determined that both implants are still fully functional and did not fail mechanically in any way. Labeling review notes the following: "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture. Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant. " "these devices can break when subjected to the increased load associated with delayed union or non-union. Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs. If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break. Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant. " failure of the patient to comply with post-operative care and sustaining an impact from a fall, likely caused or contributed to the spinous process breakage and the need for revision surgery.

 
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Brand NameNUVASIVE SPINOUS PROCESS PLATE SYSTEM
Type of DeviceSPINAL INTERLAMINAL FIXATION ORTHOSIS
Manufacturer (Section D)
NUVASIVE, INC.
san diego CA
Manufacturer Contact
paul holbrook
7475 lusk blvd.
san diego , CA 92121
8583205285
MDR Report Key2939263
Report Number2031966-2013-00001
Device Sequence Number1
Product CodeKWP
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/25/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7577035
Device LOT NumberTU1267 AND TU1950
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/17/2013
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date12/26/2012
Event Location Hospital
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/29/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/28/2013 Patient Sequence Number: 1
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