MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	482317545
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the patient was undergoing revision surgery and that during the case the tulip head became detached from the screw shaft.It was removed in the correct way using the adjustment driver without excessive force.The shaft was then removed using the driver also.The surgeon would like to know why the tulip head detached during explantation because when the patient was opened the head was intact.
Event or Problem Description
It was reported that; the customer reported that the patient was undergoing revision surgery and that during the case the tulip head became detached from the screw shaft.It was removed in the correct way using the adjustment driver without excessive force.The shaft was then removed using the driver also.The surgeon would like to know why the tulip head detached during explantation because when the patient was opened the head was intact.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 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: 6713754
• Report Number: 3005525032-2017-00078
• Device Sequence Number: 1615817
• Product Code: MNH
• UDI-Device Identifier: 04546540562357
• UDI-Public: (01)04546540562357
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

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 Model Number: 482317545
• Device Catalogue Number: 482317545
• Device Lot Number: B10021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1