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

Catalog Number 48230000

Device Problems Break (1069); Mechanical Problem (1384); Failure to Align (2522); Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/14/2016

Event Type  malfunction  

Event Description

It was reported that; on (b)(6) 2016, dr.Operated to replace the defective hardware and used triple-lock screw caps to secure the new hardware.My son continued to have constant pain and mobility problems.Further ct scans revealed the double-lock screw caps, from the (b)(6) surgery, at l4-s1 had failed.This hardware failure caused the screws to back out of place and the hardware to fall out of alignment.In addition, some of these screws were holding a rod in place.Without the screws holding it in place, the rod was literally banging around the base of the spine.On (b)(6) 2016, dr.Replaced all the defective hardware, replaced the rod which was now damaged, and used the triple-lock screw caps to hold everything in place.These two surgeries caused the patient extreme pain, all because of hardware failures.

Manufacturer Narrative

Risk assessment; device history, device evaluation and complaint history review could not be performed as no lot code was provided and the product was not returned.The exact root cause could not be determined because the devices were not returned for evaluation.

Event Description

It was reported that; on (b)(6) 2016, dr.Operated to replace the defective hardware and used triple-lock screw caps to secure the new hardware.My son continued to have constant pain and mobility problems.Further ct scans revealed the double-lock screw caps, from the december surgery, at l4-s1 had failed.This hardware failure caused the screws to back out of place and the hardware to fall out of alignment.In addition, some of these screws were holding a rod in place.Without the screws holding it in place, the rod was literally banging around the base of the spine.On (b)(6) 2016, dr.Replaced all the defective hardware, replaced the rod which was now damaged, and used the triple-lock screw caps to hold everything in place.These two surgeries caused the patient extreme pain, all because of hardware failures.

• 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: 6186839
• MDR Text Key: 63193220
• Report Number: 3005525032-2016-00161
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48230000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• 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
• Patient Age: 44 YR