MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT TITANIUM SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6421050
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); Damage to Ligament(s) (1952); Blood Loss (2597)
Date of Event	02/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No malfunction of specific devices used in the surgery has been reported by the user facility.Review of operative report referenced that poor image quality and angulation during implant preparation and placement contributed to the malplacement and breach of the all.No transfusion was required.The procedure was subsequently completed several days later; the interbody implant was left in-situ and no further problems were reported.Labeling: ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation nonunion or delayed union fracture of the vertebra neurological, vascular or visceral injury".Left in-situ.
Event or Problem Description
On (b)(6) 2017 a (b)(6) female patient underwent a lateral interbody replacement with posterior fixation procedure at l4/5.During the placement of cage the all was breached which resulted in anterior placement and a 1000 ml blood loss.The bleeding was stopped and implant was left in-situ.The remaining surgery was postponed and rescheduled for a later date.

• Brand Name: NUVASIVE COROENT TITANIUM SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6403189
• Report Number: 2031966-2017-00017
• Device Sequence Number: 635357
• Product Code: MAX
• UDI-Device Identifier: 00887517310972
• UDI-Public: 00887517310972
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 6421050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR