MAUDE Adverse Event Report: K2M, INC. DRIVER HEIGHT/ANGLE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	7501-90025
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tips of 2 capri small expandable drivers were bent intra-operatively.Surgery was successfully completed with a replacement driver and no delay.No adverse consequences or medical intervention were reported.This report will capture the second of two drivers.
Event or Problem Description
It was reported that the tips of 2 capri small expandable drivers were bent intra-operatively.Surgery was successfully completed with a replacement driver and no delay.No adverse consequences or medical intervention were reported.This report will capture the second of two drivers.
Additional Manufacturer Narrative
The device was not returned for evaluation.Device history records could not be reviewed without either the device or a valid lot number.Complaint history was reviewed and no similar complaints for the reported catalogue number were identified.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.

• Brand Name: DRIVER HEIGHT/ANGLE
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 13895785
• Report Number: 3004774118-2022-00111
• Device Sequence Number: 4277035
• Product Code: MQP
• UDI-Device Identifier: 10888857361911
• UDI-Public: 10888857361911
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 7501-90025
• Device Catalogue Number: 7501-90025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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