MAUDE Adverse Event Report: STRYKER SPINE-US HALF SADDLE TAMP TRITANIUM TL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48932010
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intra-operatively while attempting to rotate the cage using tamp, the cage did not rotate and continued move forward.The cage became too anterior to the desired positioning.
Additional Manufacturer Narrative
It was reported that the tamp used in the surgery caused no harm to the patient and a visual inspection confirmed no issues with the instrument.In addition, it was reported that since august 2018, there were 11 surgeries performed using the instrument.This instrument is a concomitant product.Concomitant product.
Event or Problem Description
It was reported there was no issue with the tamp which was used in an attempt to rotate the cage.The cage continued to move forward and became too anterior to the desired positioning.

• Brand Name: HALF SADDLE TAMP TRITANIUM TL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8354489
• Report Number: 0009617544-2019-00013
• Device Sequence Number: 1915042
• Product Code: LXH
• UDI-Device Identifier: 07613327376098
• UDI-Public: 07613327376098
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 05/20/2019

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: Health Professional
• Device Catalogue Number: 48932010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1