MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 6.5 X 45MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	03821645
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; when doctor used the spreader to distract the screws ,he found the reduction polyaxial screws's head fixed and cannot move any more.The doctor according to the fixed screw way using the screw.However, caused great difficulties of installation rod, operation time delay.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device.Has not been returned as it remains implanted in the patient and is unavailable for inspection conclusion: the plausible root cause of the event cannot be determined as the device remains implanted and is unavilable for inspection.
Event or Problem Description
It was reported that; when doctor used the spreader to distract the srcews, he found the reduction polyaxial screws's head fixed and cannot move any more.The doctor according to the fixed screw way using the screw.However, caused great difficulties of installation rod, operation time delay.

• Brand Name: XIA LP POLYAXIAL SCREW 6.5 X 45MM
• 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: 6645135
• Report Number: 3005525032-2017-00069
• Device Sequence Number: 11043589
• Product Code: NKB
• UDI-Device Identifier: 04546540149244
• UDI-Public: (01)04546540149244
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 03821645
• Device Catalogue Number: 03821645
• Device Lot Number: B42212
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 70