MAUDE Adverse Event Report: NUVASIVE, INC. COROENT SMALL INTERLOCK SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	6791716
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant fracture was confirmed via photograph that appeared to have been taken immediately following explantation.The report indicated unspecified injuries resulted from the fractured implant.No other details of the event are known.No details of the revision surgery are known.The device has not been made available for further evaluation.No radiographs have been received.Concurrent implantation of the disc replacement device may have contributed to the reported event.Labeling review: indications for use the coroent small interlock system is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (ddd) at one level from c2-t1.Caution must be taken due to potential patient sensitivity to materials.Do not implant in patients with known or suspected sensitivity to the aforementioned materials.These devices can break when subjected to the increased load associated with delayed union or nonunion.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.No product returned for evaluation.
Event or Problem Description
It was reported that on (b)(6) 2015, a (b)(6) year-old female patient received an acdf at the c6-c7 spine level.Concurrently, a cervical disc replacement device was implanted at the superior adjacent level (c5-c6).On (b)(6) 2016, the patient underwent a revision surgery that included removal of both the interbody spacer and the disc replacement device.It was reported that the interbody spacer and one of the screws had fractured.There is no evidence that the disc replacement device exhibited any fault; the reason for its removal is unknown.It was reported the patient sustained injuries as a result of the screw fracture; however, there is no information available to evaluate the nature of the reported injury.

• Brand Name: COROENT SMALL INTERLOCK SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5743603
• Report Number: 2031966-2016-00054
• Device Sequence Number: 18854017
• Product Code: OVE
• UDI-Device Identifier: 00887517362438
• UDI-Public: 00887517362438
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K142299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/22/2016

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: 6791716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2016
• Initial Report FDA Received Date: 06/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR