MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR L LOCKING PLATE LUMBAR STAND ALONE; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48667000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; patient was implanted with product on (b)(6) 2017.Patient was complaining of pain came in for x-ray., doctor discovered plate detached at l5 s1 level.Doctor is currently leaving plate in but will follow up and monitor.Doctor does not feel pain was related to plate being detached.
Additional Manufacturer Narrative
Method: risk assessment; x-rays.Results: the event was confirmed based on x-ray images.Visual, dimensional and functional analysis could not be performed as the device remains implanted.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the definitive root cause of the event cannot be determined from the given information.
Event or Problem Description
It was reported that; patient was implanted with product on (b)(6) 2017.Patient was complaining of pain came in for x-ray., doctor discovered plate detached at l5 s1 level.Doctor is currently leaving plate in but will follow up and monitor.Doctor does not feel pain was related to plate being detached.

• Brand Name: ANCHOR L LOCKING PLATE LUMBAR STAND ALONE
• 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: 7180289
• Report Number: 3005525032-2018-00002
• Device Sequence Number: 11071927
• Product Code: MAX
• UDI-Device Identifier: 07613252655732
• UDI-Public: (01)07613252655732
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48667000
• Device Catalogue Number: 48667000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR