MAUDE Adverse Event Report: K2M, INC. STRAIGHT INSERTER; TLIF II; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	3303-90151
Medical Device Problem Codes	No Apparent Adverse Event (3189); Failure to Eject (4010)
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 an aleutian tlif ii straight inserter and inner shaft were unable to be removed from an implant intra-operatively.The tip of the inserter inner shaft subsequently fractured off inside the implant.The implant and fractured inner shaft tip were left inside the patient.This report captures the inserter.
Event or Problem Description
It was reported that an aleutian tlif ii straight inserter and inner shaft were unable to be removed from an implant intra-operatively.The tip of the inserter inner shaft subsequently fractured off inside the implant.The implant and fractured inner shaft tip were left inside the patient.This report captures the inserter.
Additional Manufacturer Narrative
Upon visual inspection it was noted that there was no damage to the aleutian tlif ii straight inserter, it was the inner shaft that sustained damage.Report #3004774118-2022-00203 was filed for the inner shaft.

• Brand Name: STRAIGHT INSERTER; TLIF II
• 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: 14465752
• Report Number: 3004774118-2022-00202
• Device Sequence Number: 17324070
• Product Code: MAX
• UDI-Device Identifier: 10888857076600
• UDI-Public: 10888857076600
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150481
• 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): 08/19/2022

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: 3303-90151
• Device Catalogue Number: 3303-90151
• Device Lot Number: NKNC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/21/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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