MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT CAGE DIAM 18 X 32MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Model Number	48291832
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distraction of the cage was impossible.New implant was used to complete the surgery successfully.There was a surgical delay of 30 minutes.No adverse health consequences reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, risk assessment; result: upon device evaluation, the end caps were found attached to the cage on both sides and were jammed.The end caps are assembled during a procedure to the implant in a manner that accommodates the surgical approach.Manufacturing history review revealed no relevant anomalies.The event happened during an assembly.It is likely that the device may have been improperly assembled during a surgery, resulting the in the reported jamming.However, the exact root cause cannot be confirmed.
Event or Problem Description
It was reported that the distraction of the cage was impossible.New implant was used to complete the surgery successfully.There was a surgical delay of 30 minutes.No adverse health consequences reported.

• Brand Name: VLIFT CAGE DIAM 18 X 32MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7247750
• Report Number: 0009617544-2018-00038
• Device Sequence Number: 18856866
• Product Code: MQP
• UDI-Device Identifier: 04546540557827
• UDI-Public: (01)04546540557827
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060506
• 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): 05/24/2018

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: No Information
• Device Model Number: 48291832
• Device Catalogue Number: 48291832
• Device Lot Number: 170106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1