MAUDE Adverse Event Report: K2M, INC. AN LORDOTIC - OBLIQUE INSERTER; SIZE 10 MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6101-90167
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted retrospectively per fda request.
Event or Problem Description
This report is being submitted retrospectively per fda request.It was reported that a surgery took place in which a shaft from an oblique inserter broke intraoperatively.A piece of the shaft of the oblique inserter remains in the patient.

• Brand Name: AN LORDOTIC - OBLIQUE INSERTER; SIZE 10 MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karen ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7997336
• Report Number: 3004774118-2018-00164
• Device Sequence Number: 6548525
• Product Code: MAX
• UDI-Device Identifier: 10888857270107
• UDI-Public: 10888857270107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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: Health Professional
• Device Model Number: 6101-90167
• Device Catalogue Number: 6101-90167
• Device Lot Number: EPRX
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 10/23/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown