MAUDE Adverse Event Report: STRYKER SPINE-US 10X32X6DEG-11; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48956106
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
On (b)(6) 2019, an x-ray suggested the cage was broken.No revision surgery is planned as patient has no complaint of pain or any other adverse event.
Event or Problem Description
On (b)(6) 2019, an x-ray suggested the cage was broken.No revision surgery is planned as patient has no complaint of pain or any other adverse event.
Event or Problem Description
On 22 may 2019, an x-ray suggested the cage was broken.No revision surgery is planned as patient has no complaint of pain or any other adverse event.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned because it remains implanted in patient.Device and complaint history and no relevant manufacturing issues or similar complaints were identified.Without the device, a definite root cause cannot be determined.It is unknown if fusion occurred, but based on the length of implantation (1 year), the most likely root cause is fatigue fracture due to possible pseudoarthrosis.

• Brand Name: 10X32X6DEG-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: 8724848
• Report Number: 3004024955-2019-00024
• Device Sequence Number: 19264874
• Product Code: MAX
• UDI-Device Identifier: 07613327295146
• UDI-Public: 07613327295146
• Combination Product (Y/N): N
• PMA/510(K) Number: K162262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2020

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: Health Professional
• Device Model Number: 48956106
• Device Catalogue Number: 48956106
• Device Lot Number: AP9D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 08/01/2019; 08/28/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 08/05/2019; 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 80