MAUDE Adverse Event Report: NUVASIVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1221250P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation as no product malfunction has been alleged.No radiographs or images to confirm the reported event.Review of the reported information suggests intra-operative surgical technique may have contributed to the alleged event.Labeling review: potential adverse events and complications "as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves" "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, metal sensitivity or allergic reaction to a foreign body, infection, decrease in bone density due to stress shielding, pain, discomfort or abnormal sensations due to the presence of the device, nerve damage due to surgical trauma, bursitis, dural leak." no product malfunction alleged.
Event or Problem Description
On (b)(6) 2019, patient underwent a surgical extreme lateral interbody fusion (xlif) procedure at l4 to l5 vertebral levels.During the procedure, a dural tear occurred.The dural tear was repaired and the procedure was completed without any reported issues.No revision procedure is planned at this time.
Event or Problem Description
Additional information was received.As per reporter, the tear was performed by the instrument during decompression.
Additional Manufacturer Narrative
Additional information was received.As per reporter, the tear was performed by the instrument during decompression.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9413935
• Report Number: 2031966-2019-00259
• Device Sequence Number: 19546055
• Product Code: LXH
• UDI-Device Identifier: 00887517726681
• UDI-Public: 887517726681
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K163230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: Health Professional
• Device Model Number: 1221250P2
• Device Lot Number: ML2057
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 12/16/2019
• 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: Hospitalization
• Patient Age: 61 YR