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

Model Number	8594530
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	07/21/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 5892481
• Report Number: 2031966-2016-00060
• Device Sequence Number: 1077482
• Product Code: OVD
• UDI-Device Identifier: 00887517322920
• UDI-Public: 00887517322920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Model Number: 8594530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR