MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK 8MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48955086
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; cage appear to collapse in situ.
Additional Manufacturer Narrative
Device history review, complaint history review, risk assessment.Due to the lack of complete x-ray and ct images, the fracture of the cage cannot be determined or concluded.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The root cause could not be determined conclusively due to the lack of information and the complaint device was still implanted in the patient.
Event or Problem Description
It was reported that; cage appear to collapse in situ.
Additional Manufacturer Narrative
Upon follow-up, it was confirmed that revision surgery was performed in (b)(6) 2016.The explanted cage was discarded by the hospital and not available for the return.It's confirmed that no fracture was recognized on the supplemental fixation system.There was no fusion in the patient.Based on the provided information, the cause of the reported event could not be determined.
Event or Problem Description
It was reported that; cage appear to collapse in situ.

• Brand Name: 8MM X 6DEG X 11MM X 28MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA
• MDR Report Key: 6130463
• Report Number: 3005525032-2016-00150
• Device Sequence Number: 11051427
• Product Code: MAX
• UDI-Device Identifier: 07613327118063
• UDI-Public: (01)07613327118063
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2018

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: 48955086
• Device Catalogue Number: 48955086
• Device Lot Number: A96D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided; 03/22/2018
• Initial Report FDA Received Date: 11/28/2016
• Supplement Report FDA Received Date: 01/26/2017; 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1