MAUDE Adverse Event Report: STRYKER SPINE-US AVS UNILIF WEDGENOSE VERTEBRAL SPACER 12X25X4-11; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48395124
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Neuropathy (1983); Pain (1994); Numbness (2415)
Date of Event	12/15/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that a cage which was implanted on (b)(6) 2014, had slid out from l4/l5 and he will undergo corrective surgery (b)(6) 2018 due to excruciating pain.Patient reported the same type of pain radiating down right leg, neuropathy, and numbness in right foot, which got worse since (b)(6) 2014, when symptoms started.Device will be removed.In addition, patient reported that x-rays show, cage moved about 3/4 inch toward posterior and right and physician stated, "it is partially fused in a bad place.He has to cut it out." patient additionally reported that, "the ct scans show halo around screws which might indicate loosening according to the physician.".
Event or Problem Description
The patient reported that a cage which was implanted on (b)(6) 2014, had slid out from l4/l5 and he will undergo corrective surgery (b)(6) 2018 due to excruciating pain.Patient reported the same type of pain radiating down right leg, neuropathy, and numbness in right foot, which got worse since (b)(6) 2014, when symptoms started.Device will be removed.In addition, patient reported that x-rays show, cage moved about 3/4 inch toward posterior and right and physician stated, "it is partially fused in a bad place.He has to cut it out." patient additionally reported that, "the ct scans show halo around screws which might indicate loosening according to the physician.".
Additional Manufacturer Narrative
The customer reported event was confirmed upon x-ray images review.Per correspondence with patient, revision surgery was performed and protruding part of implant was removed by the surgeon while the majority part remains inside.No product related issue or surgical technique related issues were observed in the images provided.Cage is observed to be well positioned from the images provided.Device was not returned and lot# was not provided therefore, device inspection, device history review, and complaint history review could not be completed.The cage migration is a known risk and the surgical techniques states that the surgeon must advise the patient of this fact and warn of the potential consequences.Prior to adequate maturation of the fusion mass, implanted spinal instrumentation may need additional help to accommodate full load bearing.Conclusion: the exact root cause of the reported event could not be determined.However some of the plausible contributing factor includes: patient non-fusion, too much instantaneous load, implant under sizing.

• Brand Name: AVS UNILIF WEDGENOSE VERTEBRAL SPACER 12X25X4-11
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7635286
• Report Number: 0009617544-2018-00153
• Device Sequence Number: 13841701
• Product Code: MAX
• UDI-Device Identifier: 07613252094722
• UDI-Public: (01)07613252094722
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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: 48395124
• Device Catalogue Number: 48395124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 10/22/2018
• 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: Required Intervention
• Patient Age: 44 YR