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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PRECEPT SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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NUVASIVE, INC. NUVASIVE PRECEPT SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 8896545
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994)
Event Date 09/23/2015
Event Type  Injury  
Manufacturer Narrative
There is no known malfunction of the implanted devices or any information suggesting difficulty in initial placement of the construct. It is unknown if the patient followed post-operative care instructions. No root cause has not been determined and no conclusion can be drawn; information suggests community-acquired infection. Product labeling indicates: "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, and vascular or visceral injury, metal sensitivity or allergic reaction to a foreign body, infection". Device not returned.
 
Event Description
In (b)(6) 2015 a (b)(6) male had a procedure done for a bulging disc, spine level unknown. On (b)(6) 2015 the patient was implanted with a posterior fixation at l4-l5. No complications were noted based on surgeon's operative notes. On (b)(6) 2015 an intervention took place for the incision and drainage of the lumbar wound. No nectrotic tissue was visualized. Bacitracin infused saline was used to irrigate the wound copiously. Culture results showed light growth of escherichia coli. Patient was treated with wound vacs in the left lateral and midline of the back. Additional unknown antibiotic treatment was prescribed following wound debridement. Wound reportedly healed in (b)(6) 2016.
 
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Brand NameNUVASIVE PRECEPT SPINAL SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
NUVASIVE, INC.
7475 lusk blvd
san diego CA 92121
Manufacturer Contact
deborah silva
7475 lusk blvd
san diego, CA 92121
8589091830
MDR Report Key5709724
MDR Text Key46916454
Report Number2031966-2016-00045
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517387547
UDI-Public00887517387547
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 06/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number8896545
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2016 Patient Sequence Number: 1
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