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

Catalog Number 48230000

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Discomfort (2330); Injury (2348)

Event Date 08/25/2016

Event Type  Injury  

Event Description

It was reported that; on (b)(6) 2016 surgeon operated performed the initial surgery.The surgeon indicated that the patient began to present discomfort so requested x-rays and found a loose blocker for the last screw.For this reason, he had to intervene for a second time on (b)(6) 2016, where only change blocker was performed.

Manufacturer Narrative

Lot# e9g; visual inspection, device history review, complaint history review, risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Inspection of the device revealed indentations on the base of the blocker that were representative of final tightening being performed.However, the indentations were not symmetric across the blocker, suggesting that the blocker was not optimally seated on the rod during final tightening.The most likely cause of the reported event is sub-optimal seating of the blocker on the rod during final tightening with the possible use of a non-stryker device contributing to the event.

Event Description

It was reported that; on (b)(6) 2016 surgeon operated performed the initial surgery.The surgeon indicated that the patient began to present discomfort so requested x-rays and found a loose blocker for the last screw.For this reason, he had to intervene for a second time on (b)(6) 2016, where only change blocker was performed.

• 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6042134
• MDR Text Key: 57915759
• Report Number: 3005525032-2016-00133
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 04546540560193
• UDI-Public: (01)04546540560193
• Combination Product (y/n): N
• 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: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48230000
• Device Lot Number: E9G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2015
• 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
• Patient Outcome(s): Required Intervention