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

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.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Type of Device: ORTHOSIS, 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 Key: 5709724
• MDR Text Key: 46916454
• Report Number: 2031966-2016-00045
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517387547
• UDI-Public: 00887517387547
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• 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 Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 8896545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR