MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 100MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482318500
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inside threads on the screw stripped during final tightening.This was an s2 aller screw.The doc didn't want to final tighten to 12 nm for fear of loosing a fixation point.He said he got it close but not completely final tightened.He left it the way it was.Didn't add any time to the case.
Additional Manufacturer Narrative
Method: risk assesment: result: no lot # was provided, so a manufacturing record review could not be performed.The screw was not returned for inspection nor a lot number was provided as the device is implanted in the patient.Conclusion: the possible root cause of the event could not be determined by the given information.
Event or Problem Description
It was reported that the inside threads on the screw stripped during final tightening.This was an s2 aller screw.The doc didn't want to final tighten to 12 nm for fear of loosing a fixation point.He said he got it close but not completely final tightened.He left it the way it was.Didn't add any time to the case.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 100MM
• 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: 5623825
• Report Number: 3005525032-2016-00049
• Device Sequence Number: 18838897
• Product Code: MNH
• UDI-Device Identifier: 04546540598547
• UDI-Public: (01)04546540598547
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2016

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: 482318500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1