MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.5 X 40 MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482315540
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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 went to remove the l5 screw on the right and while removing it with the correct driver the tulip popped off.He was able to remove the bone screw with the quick out driver though.No additional time was added to the case and the patient was not effected.
Additional Manufacturer Narrative
Method: risk assessment; results: no lot # was provided, so a manufacturing record review could not be performed.Conclusion: the plausible root cause cannot be determined conclusively.
Event or Problem Description
It was reported that the surgeon went to remove the l5 screw on the right and while removing it with the correct driver the tulip popped off.He was able to remove the bone screw with the quick out driver though.No additional time was added to the case and the patient was not effected.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.5 X 40 MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5567918
• Report Number: 3005525032-2016-00036
• Device Sequence Number: 18915063
• Product Code: MNH
• UDI-Device Identifier: 04546540562043
• UDI-Public: (01)04546540562043
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K071373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 482315540
• Device Lot Number: UNKNOWN
• 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
• Initial Report FDA Received Date: 04/11/2016
• Supplement Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1