MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR L LUMBAR STAND ALONE- CAGE 10 X 22 X 30 MM X 8 DEG; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 48662108

Device Problems Crack (1135); Fracture (1260)

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

Event Date 02/28/2018

Event Type  malfunction  

Event Description

It was reported that the cage cracked while the surgeon was lagging the third and final screw.The cage was left implanted in the patient.There are no reports of adverse health consequences to the patient.

Manufacturer Narrative

The customer reported event was confirmed via correspondence with the sales representative.The cage was not returned for evaluation nor the lot number was provided therefore device inspection, complaint history review and device history review cannot be performed.Due to the device not being returned, a definite root cause cannot be determined.According to the risk file, cage breakage may be caused by: user applies cantilever force on screwdriver while inserting the screw, previously deformed of damaged screwdriver used, screw hole inadequately prepared, excessive torsional/axial force applied by the user.

Event Description

It was reported that the cage cracked while the surgeon was lagging the third and final screw.The cage was left implanted in the patient.There are no reports of adverse health consequences to the patient.

• Brand Name: ANCHOR L LUMBAR STAND ALONE- CAGE 10 X 22 X 30 MM X 8 DEG
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: marta koutsogiannis ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7379295
• MDR Text Key: 103924993
• Report Number: 3005525032-2018-00012
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07613252601920
• UDI-Public: (01)07613252601920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

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: 48662108
• Device Catalogue Number: 48662108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1