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

Model Number 48230000

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problems Pain (1994); Injury (2348)

Event Date 11/26/2017

Event Type  Injury  

Event Description

It was reported that; l3-l5 mis tlif, patient complained of pain.Imaging showed l3 and l4 set screws floating.Revised pt today.Hospital has kept 3 set screws to examine.It was noticed by the surgeon upon the imaging results.

Manufacturer Narrative

According to the representative, the hospital review believes the event was because of surgeon error as the blockers were inserted in the screw at a fixed angle and not seated in correctly (cross-threaded).This would cause instability in the structure and may cause the blockers to back out over time if they were not properly seated and locked down during the initial surgery.According to the representative, the surgeon applied the correct amount of torque and excessive force was not applied.As the products were not returned, a definite root cause cannot be determined.

Event Description

It was reported that; l3-l5 mis tlif, patient complained of pain.Imaging showed l3 and l4 set screws floating.Revised pt today.Hospital has kept 3 set screws to examine.It was noticed by the surgeon upon the imaging results.

• Brand Name: XIA 3 TITANIUM BLOCKER
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7137937
• MDR Text Key: 95846048
• Report Number: 3005525032-2017-00112
• Device Sequence Number: 1
• Product Code: MNH
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48230000
• Device Catalogue Number: 48230000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2018
• 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
• Patient Outcome(s): Required Intervention