MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR L LUMBAR STAND ALONE- CAGE 12 X 22 X 30 MM X 8 DEG; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 48662128

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2018

Event Type  malfunction  

Event Description

The inserter came off of the cage and the cage broke upon insertion.The issue was resolved upon re-insertion of the same size cage on the same inserter and all in one guide.There was a reported 4-5 minutes of operating room time to get all fragments out of interspace.There are no reports of adverse health consequences.

Manufacturer Narrative

Method: risk assessment; result: the reported event could not be confirmed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.The sales rep reported that the surgeon did not tighten the cage perfectly with locking set screw on the all in one guide because of which the cage came off and it broke.Conclusion: the most likely cause of the reported event was determined to be user error.

Event Description

The inserter came off of the cage and the cage broke upon insertion.The issue was resolved upon re-insertion of the same size cage on the same inserter and all in one guide.There was a reported 4-5 minutes of operating room time to get all fragments out of interspace.There are no reports of adverse health consequences.

• Brand Name: ANCHOR L LUMBAR STAND ALONE- CAGE 12 X 22 X 30 MM X 8 DEG
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 7266761
• MDR Text Key: 100146082
• Report Number: 3005525032-2018-00006
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07613252601968
• UDI-Public: (01)07613252601968
• Combination Product (y/n): N
• PMA/PMN Number: K120869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

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
• Device Operator: No Information
• Device Model Number: 48662128
• Device Catalogue Number: 48662128
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1