MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM BLOCKER; PEDICLE SCREW SPINAL SYSTEM

Model Number 48230000

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Torn Material (3024)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/29/2017

Event Type  malfunction  

Event Description

It was reported that; the blocker stripped.Had to use a new blocker.

Manufacturer Narrative

Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The inner hex shape was stripped and deformed.The bottom thread was also deformed.Conclusion: the most likely root cause is user error, instrument not seated properly into implant.

Event Description

It was reported that; the blocker stripped.Had to use a new blocker.

• Brand Name: XIA 3 TITANIUM BLOCKER
• 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: 6522741
• MDR Text Key: 74010413
• Report Number: 3005525032-2017-00051
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 04546540560193
• UDI-Public: (01)04546540560193
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48230000
• Device Catalogue Number: 48230000
• Device Lot Number: A9M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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