MAUDE Adverse Event Report: K2M, INC. AN INSERTER; SIZE 8.5 MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	602-90776
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the knob of an aleutian an inserter and inner shaft broke off during intra-operative implant placement.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the inserter.
Additional Manufacturer Narrative
It was reported that the inner shaft knob fractured.This indicates that the outer shaft did not contribute to the failure.Report # 3004774118-2022-00201 has been submitted which captures the inner shaft.H3 other text : device was discarded.
Event or Problem Description
It was reported that the knob of an aleutian an inserter and inner shaft broke off during intra-operative implant placement.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the inserter.

• Brand Name: AN INSERTER; SIZE 8.5 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 karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14465735
• Report Number: 3004774118-2022-00200
• Device Sequence Number: 14611825
• Product Code: MAX
• UDI-Device Identifier: 10888857120471
• UDI-Public: 10888857120471
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: 602-90776
• Device Catalogue Number: 602-90776
• Device Lot Number: TBC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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