MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482317550

Device Problems Break (1069); Detachment Of Device Component (1104); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2016

Event Type  malfunction  

Event Description

Per reported event; the polyaxial tulip head broke off of the screw while inserting the blocker.

Manufacturer Narrative

Method: risk assessment: results: review of the correspondence confirms that the tulip disengagement occurred on the screw during final tightening.The sales representative confirmed that the torque wrench and anti-torque key were used as directed, however since the product is not available for evaluation.Conclusion: the cause of this issue is likely to be multi-factorial in nature and cannot be conclusively determined.

Event Description

Per reported event; the polyaxial tulip head broke off of the screw while inserting the blocker.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5464084
• MDR Text Key: 39458625
• Report Number: 3005525032-2016-00020
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 04546540562364
• UDI-Public: 04546540562364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 482317550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1