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

Model Number	03801880
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2017
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6358179
• Report Number: 3005525032-2017-00018
• Device Sequence Number: 768469
• Product Code: NKB
• UDI-Device Identifier: 04546540433527
• UDI-Public: (01)04546540433527
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1