MAUDE Adverse Event Report: NUVASIVE, INC. ORTHOPEDIC MANUAL SURGICAL INSTRUMENT; ALGI COBB ELEVATOR

Model Number	6900222
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.A review of photographic images has been performed and confirm the reported event.Labeling review: ".The instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury." ".The physical characteristics required for many instruments do not permit them to be manufactured from implantable materials.If any broken fragments of instruments remain in the body of a patient, they could cause allergic reactions or infections.If an instrument breaks in surgery and fragments go into the patient, these pieces should be removed prior to closure and should not be implanted." no product has been returned.
Event or Problem Description
During an extreme lateral interbody fusion procedure it was reported the cobb elevator was inserted into the disc space and the distal part of the cobb broke off.Cobb was surgically removed, no patient injury reported.
Additional Manufacturer Narrative
Supplemental report submitted to update brand name and common device name of the initial report.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Common Device Name: ALGI COBB ELEVATOR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7314940
• Report Number: 2031966-2018-00020
• Device Sequence Number: 10813313
• Product Code: LXH
• UDI-Device Identifier: 00887517384324
• UDI-Public: 00887517384324
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K172123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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: 6900222
• Device Lot Number: FD2220801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 10/16/2018
• 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: 45 YR