MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 0DEG X 9MM X 23MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48950100
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cage broke during spine surgery due to patient in pain.Additional device available for replacement of broken cage.No adverse consequences or delay.Sales rep need replacement.Update 1/24/2017: "surgery was bc of pain most likely¿anyways, the cage broke during insertion due to the surgeon using a rotation technique which is when you put in on side and rotate to its proper cranial/caudal position".
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Cage main body fracture was confirmed via visual inspection.The most likely cause of the reported event was determined to be patient and user related.
Event or Problem Description
It was reported that the cage broke during spine surgery due to patient in pain.Additional device available for replacement of broken cage.No adverse consequences or delay.Sales rep need replacement.Update 1/24/2017: "surgery was bc of pain most likely¿anyways, the cage broke during insertion due to the surgeon using a rotation technique which is when you put in on side and rotate to its proper cranial/caudal position".

• Brand Name: 10MM X 0DEG X 9MM X 23MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6326956
• Report Number: 3004024955-2017-00010
• Device Sequence Number: 1021483
• Product Code: MAX
• UDI-Device Identifier: 07613327117295
• UDI-Public: (01)07613327117295
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 04/26/2017

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: No Information
• Device Catalogue Number: 48950100
• Device Lot Number: ADTM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR