MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 45MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	03829645
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; upon loading a redux screw, the upper tab popped off with very little to no pressure exerted on it.
Additional Manufacturer Narrative
Risk assessment; visual, functional analysis and device history could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.The root cause of the event cannot be determined.
Event or Problem Description
It was reported that; upon loading a redux screw, the upper tab popped off with very little to no pressure exerted on it.

• Brand Name: XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 45MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6358190
• Report Number: 0009617544-2017-00061
• Device Sequence Number: 38482
• Product Code: MNI
• UDI-Device Identifier: 07613154407897
• UDI-Public: (01)07613154407897
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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 Catalogue Number: 03829645
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1