MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR L LUMBAR STAND ALONE- CAGE 14 X 22 X 30 MM X 12 DEG; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48662142
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon used the cage and followed the normal surgical tec for insertion.No issue was noticed during the case with the plate placement.Since the procedure the patient has been rescanned and anterior plate has moved and is not securely located on the front of the anchor l cage.The surgeon will not revise the cages plate unless patient shows issues and at this stage patient is fine.
Additional Manufacturer Narrative
Method: risk assessment; results: device inspection, device history review and complaint history review could not be performed since the device is still implanted.Conclusion: the plausible cause of the reported event cannot be identified conclusively as the device remains implanted.
Event or Problem Description
It was reported that the surgeon used the cage and followed the normal surgical tec for insertion.No issue was noticed during the case with the plate placement.Since the procedure the patient has been rescanned and anterior plate has moved and is not securely located on the front of the anchor l cage.The surgeon will not revise the cages plate unless patient shows issues and at this stage patient is fine.

• Brand Name: ANCHOR L LUMBAR STAND ALONE- CAGE 14 X 22 X 30 MM X 12 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: 6034625
• Report Number: 3005525032-2016-00128
• Device Sequence Number: 11003355
• Product Code: MAX
• UDI-Device Identifier: 07613252601975
• UDI-Public: (01)07613252601975
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2016

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: 48662142
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 87