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

Catalog Number 03821645

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

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

Event Date 07/26/2015

Event Type  malfunction  

Event Description

It was reported that; doctor reported that 3 screw heads were pulled while using suk system during derotation process.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: deformation of the screw tulip base was confirmed and suggests that excess force was applied during the derotation maneuver.These circumstances could not be replicated during device evaluation.Conclusion: the root cause of the reported event could not be determined conclusively.

Event Description

It was reported that; doctor reported that 3 screw heads were pulled while using suk system during derotation process.

• Brand Name: XIA LP POLYAXIAL SCREW 6.5 X 45MM
• 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: 5020859
• MDR Text Key: 24667550
• Report Number: 3005525032-2015-00101
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: K060361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/28/2015

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
• Device Operator: No Information
• Device Catalogue Number: 03821645
• Device Lot Number: B53610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2015
• 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