MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	UNK_SPN
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was placing the cage and upon placement he wanted to articulate the arm and make adjustments.As he started to expand the cage the seal that's attached to the inserter where the tubing set attaches broke off.
Additional Manufacturer Narrative
Investigation is in progress; a final report will be sent once investigation is completed.
Event or Problem Description
It was reported that the surgeon was placing the cage and upon placement he wanted to articulate the arm and make adjustments.As he started to expand the cage the seal that's attached to the inserter where the tubing set attaches broke off.
Additional Manufacturer Narrative
Method: risk assessment; results: the device was not received by the complaint department and cannot be evaluated.The manufacturing records could not be reviewed because the lot # of the device is unknown.Conclusion: a plausible root cause of the reported event cannot be determined conclusively as the instrument was not returned for evaluation.
Event or Problem Description
It was reported that the surgeon was placing the cage and upon placement he wanted to articulate the arm and make adjustments.As he started to expand the cage the seal that's attached to the inserter where the tubing set attaches broke off.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5567921
• Report Number: 3004024955-2016-00042
• Device Sequence Number: 16228679
• Product Code: LXH
• UDI-Device Identifier: 07613327066760
• UDI-Public: (01)07613327066760
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• 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,Followup
• Report Date (Section B): 03/15/2016

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: UNK_SPN
• Device Lot Number: U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/11/2016
• Supplement Report FDA Received Date: 07/26/2016; 08/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1