MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 4.5 X 40MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 03821440

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Mechanical Jam (2983)

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

Event Date 08/05/2015

Event Type  malfunction  

Event Description

It was reported that; during medical procedure for repositioning the surgeon identify that 2 of the poliaxial screws remain bloqued, what means problems to remove and non conformity from the surgeon.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the failure mode of the device suggests that the screws had been over tightened during final tightening; the head of the bone screw sits flush with the base of the tulip when it should protrude slightly.These devices are one time use and should not be constantly final tightened, loosened and re-tightened, as this can cause deformation to the device.Conclusion: the most likely cause of the reported event is over-tightening of the device during final tightening.

Event Description

It was reported that; during medical procedure for repositioning the surgeon identified that 2 of the poliaxial screws remain bloqued, which created problems to remove and non conformity from the surgeon.

• Brand Name: XIA LP POLYAXIAL SCREW 4.5 X 40MM
• 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: 5126980
• MDR Text Key: 27861303
• Report Number: 3005525032-2015-00120
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 08/10/2015

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: 03821440
• Device Lot Number: B24881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2012
• 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