MAUDE Adverse Event Report: K2M, INC. AN LORDOTIC - OBLIQUE INSERTER; SIZE 8.5X28 MM; ORTHOPEDIC MANUAL INSTRUMENT, REUSABLE

Model Number	5303-90001
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the tongs (tip) of an aleutian an coronal inserter became deformed during surgery.The procedure was completed successfully with a five-minute surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion h3 other text : no product returned.
Event or Problem Description
A physician reported that the tongs (tip) of an aleutian an coronal inserter became deformed during surgery.The procedure was completed successfully with a five-minute surgical delay and no adverse consequence to the patient.

• Brand Name: AN LORDOTIC - OBLIQUE INSERTER; SIZE 8.5X28 MM
• Common Device Name: ORTHOPEDIC MANUAL INSTRUMENT, REUSABLE
• 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: 14950358
• Report Number: 3004774118-2022-00262
• Device Sequence Number: 20569211
• Product Code: LXH
• UDI-Device Identifier: 10888857110458
• UDI-Public: 10888857110458
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/29/2022

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: 5303-90001
• Device Catalogue Number: 5303-90001
• Device Lot Number: DGKY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown