MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF SYRINGE BODY GREEN O-RING; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	800347
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; three of the green rings broke during the procedure.
Additional Manufacturer Narrative
Risk assessment; no lot # was provided, so a manufacturing record review could not be performed.The plausible root cause of the reported event is user related, specifically misalignment of the syringe and inserter during assembly causing breakage of the o-rings.
Event or Problem Description
It was reported that; three of the green rings broke during the procedure.

• Brand Name: ACCULIF SYRINGE BODY GREEN O-RING
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6239295
• Report Number: 3004024955-2017-00004
• Device Sequence Number: 521082
• Product Code: MAX
• UDI-Device Identifier: 07613327067095
• UDI-Public: (01)07613327067095
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132505
• 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): 03/10/2017

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: 800347
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1