MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 11MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48951106
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cage migrated and retro pulsed into the canal, patient was doing heavy lifting postop.The patient was complaining of pain and underwent revision surgery.
Additional Manufacturer Narrative
Method: x-ray film review, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via x-ray films review.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The reported device was not returned for evaluation.It was confirmed that the cage only migrated, no deformation or fracture was reported.It was reported that the patient was doing heavy lifting postop.The surgical technique states, "the surgeon must warn the patient of the surgical risks and make them aware of possible adverse effects.The surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device." conclusion: the most likely root cause of the reported event was determined to be high post-op activity by the patient (heavy lifting).
Event or Problem Description
It was reported that the cage migrated and retro pulsed into the canal, patient was doing heavy lifting postop.The patient was complaining of pain and underwent revision surgery.

• Brand Name: 10MM X 6DEG X 11MM X 23MM
• 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: 7970775
• Report Number: 3004024955-2018-00050
• Device Sequence Number: 1681670
• Product Code: MAX
• UDI-Device Identifier: 07613327117585
• UDI-Public: 07613327117585
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: Health Professional
• Device Catalogue Number: 48951106
• Device Lot Number: AYK4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 01/31/2019
• 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