MAUDE Adverse Event Report: NUVASIVE, INC. COROENT XLR STANDALONE SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 8594530

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

Radiographs were not received.On (b)(6) 2016, patient underwent surgery for osteolysis, at which time, surgeon elected to remove fractured screw.Implant has not yet been returned for evaluation.No further evaluation of the product can be completed at this time.Patient's bone quality is unknown.The degree of spinal instability is unknown.Patient has had multiple spine surgeries and is in poor health.The root cause of this reported event has not been determined.Review of labeling notes: warnings cautions and precautions: ".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, neurological injury, and vascular or visceral injury." device not returned.

Event Description

On (b)(6) 2016, (b)(6) male patient underwent an alif procedure at l5-s1.On (b)(6) 2016, a post-operative interbody device screw fracture was reported at the l5 disc space.Patient underwent additional surgical procedure to treat osteolysis on (b)(6) 2016, during which time, the fractured screw was removed successfully.No patient injury reported.

• Brand Name: COROENT XLR STANDALONE SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: naren hariharan ; 7475 lusk blvd; san diego, CA 92121 ; 8589093347
• MDR Report Key: 5892481
• MDR Text Key: 52616663
• Report Number: 2031966-2016-00060
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00887517322920
• UDI-Public: 00887517322920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8594530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR