MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR L LUMBAR STAND ALONE- CAGE 12 X 25 X 35 MM X 8 DEG; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48663128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screw went through the cage.Yes, replacement hardware was used.
Additional Manufacturer Narrative
Method: none.Result: device was confirmed to be a concomitant product.No issue was reported with this device via the complaint reported.Conclusion: device was confirmed to be a concomitant product.No issue was reported with this device via the complaint reported.
Event or Problem Description
It was reported that; screw went through the cage.Yes, replacement hardware was used.

• Brand Name: ANCHOR L LUMBAR STAND ALONE- CAGE 12 X 25 X 35 MM X 8 DEG
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6015099
• Report Number: 3005525032-2016-00125
• Device Sequence Number: 16498827
• Product Code: MAX
• UDI-Device Identifier: 07613252602194
• UDI-Public: (01)07613252602194
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K120869
• 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): 09/12/2016

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 Catalogue Number: 48663128
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2016
• Supplement Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1