MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK 13MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48955136
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; wrong inserter was used by rep.Fracture of cage occurred.Another cage was implanted.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; the device was inspected and the complaint cage was confirmed to be fractured.No relevant manufacturing issues were identified as all units met specifications.The root cause of the reported event was determined to be user error.
Event or Problem Description
It was reported that; wrong inserter was used by rep.Fracture of cage occurred.Another cage was implanted.

• Brand Name: 13MM 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: 6530319
• Report Number: 3004024955-2017-00019
• Device Sequence Number: 10819342
• Product Code: MAX
• UDI-Device Identifier: 07613327118117
• UDI-Public: (01)07613327118117(11)160414(10)AE8A
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2017

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 Model Number: 48955136
• Device Catalogue Number: 48955136
• Device Lot Number: AE8A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 125