MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT EXPANDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48300200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during impaction of a cage, the cap of a vlift expander detached and broke intra operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a sixty min surgical delay.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed for this lot as a valid lot code was not provided and could not be obtained.Correspondence with the field representative suggests that high impaction force was not used.As the device was not available for investigation, the failure mode could not be confirmed, and a root cause could not be determined conclusively.H3 other text: device not returned for evaluation.
Event or Problem Description
It was reported that during impaction of a cage, the cap of a vlift expander detached and broke intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a 60 min surgical delay.

• Brand Name: VLIFT EXPANDER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11216496
• Report Number: 0009617544-2021-00007
• Device Sequence Number: 3556560
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: 07613327266986
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/26/2021

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: 48300200
• Device Catalogue Number: 48300200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1