MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT EXPANDER; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	48300200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
Physician reported that a vlift expander handle fractured intra-operatively during implant placement.Surgery was completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Corrected information: b.5.Updated from "physician reported that a vlift expander handle fractured intra-operatively during implant placement.Surgery was completed with no delay.No adverse consequences or medical intervention were reported" to "physician reported that a vlift expander handle fractured intra-operatively during implant placement.Surgery was completed with no delay.No adverse consequences or medical intervention were reported.Upon further review, the reported event did not, and has not previously, lead to serious deterioration in the state of health of a patient or user and is not likely to do so." d.10.Product available to stryker updated from 'no' to 'reurn' d.10.Returned to manufacturer on updated from 'blank' to '02/26/2020' h.3.Updated from 'return status of the device is unknown' to 'device evaluation anticipated, but not yet begun'.
Event or Problem Description
Physician reported that a vlift expander handle fractured intra-operatively during implant placement.Surgery was completed with no delay.No adverse consequences or medical intervention were reported.Upon further review, the reported event did not, and has not previously, lead to serious deterioration in the state of health of a patient or user and is not likely to do so.
Additional Manufacturer Narrative
Corrected information: b5 has been updated.H6 coding has been updated.Visual inspection of the returned device found that the shaft of the draw is fractured off of the knob.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device was manufactured in 2006.Complaint history was reviews and two similar complaints, received in 2014, were identified.A complete review of these records indicates that the fracture is not specific to this lot and both events related to this lot were attributed to normal device wear.Additionally, the occurrence of this event across all vlift expanders is significantly below the predicted threshold.From instruments general ifu, "the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order." the most likely cause of reported event is normal wear due to age.
Event or Problem Description
Physician reported that a vlift expander handle fractured intra-operatively during implant placement.Surgery was completed with no delay.No adverse consequences or medical intervention were reported.

• Brand Name: VLIFT EXPANDER
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9513541
• Report Number: 0009617544-2019-00145
• Device Sequence Number: 2695718
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: 07613327266986
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2020

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
• Device Lot Number: 063286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: 11/24/2019
• Supplement Date Received by Manufacturer: 02/20/2020; 03/30/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/20/2020; 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 75