MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ILIOS XIA POLYAXIAL SCREW 8.5 X 80MM; PEDICLE SCREW SPINAL SYSTEM

Model Number 03801880

Device Problems Mechanical Problem (1384); Connection Problem (2900)

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

Event Date 01/31/2017

Event Type  malfunction  

Event Description

It was reported that; surgeon placed a neutral cross connector in conjunction with an 8.5x80 screw at the left iliac.When trying to place a blocker/set screw into the 8.5 x 80 screw, he was unable thread it in completely (unable to final tighten).He was frustrated because he did everything "by the book." he was forced to extract the 8.5 x 80 screw and replace with another screw.Upon implanting the new screw, he was able to easily place the blocker and final tighten appropriately.

Event Description

It was reported that; surgeon placed a neutral cross connector in conjunction with an 8.5x80 screw at the left iliac.When trying to place a blocker/set screw into the 8.5 x 80 screw, he was unable thread it in completely (unable to final tighten).He was frustrated because he did everything "by the book." he was forced to extract the 8.5 x 80 screw and replace with another screw.Upon implanting the new screw, he was able to easily place the blocker and final tighten appropriately.

• Brand Name: ILIOS XIA POLYAXIAL SCREW 8.5 X 80MM
• 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: 6358179
• MDR Text Key: 68599445
• Report Number: 3005525032-2017-00018
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540433527
• UDI-Public: (01)04546540433527
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060361
• 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: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 03801880
• Device Catalogue Number: 03801880
• Device Lot Number: 064378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2006
• 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