MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482317545
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the sales rep reported that the head of the screw came off while the surgeon was trying to reducing a spondylolisthesis (grade 2).The slip was significant and the surgeon, was trying to reduce this to normal sagittal balance.The surgeon was using the cork screw persuader as per the ifu.There was a significant surgical delay of approximately 45 minutes because the screw and rod needed to be replaced.Update: the customer further reported that the case was an l5/s1 correction for a grade 2 spondylolisthesis with posterior decompression and expandible cage.
Additional Manufacturer Narrative
Method: visual analysis, device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and not relevant manufacturing issues were identified.Per the surgical technique, all correction maneuvers should be performed prior to final tightening.The increased rigidity of the construct after final tightening may have contributed to the tulip disengaging during the maneuver, as this puts a great deal of stress on the single screw.Conclusion: the most likely cause of the reported event is the application of excessive stress on the screw as a result of the construct configuration with the high angulation of the screw contributing to the event.
Event or Problem Description
It was reported that; the sales rep reported that the head of the screw came off while the surgeon was trying to reducing a spondylolisthesis (grade 2).The slip was significant and the surgeon, was trying to reduce this to normal sagittal balance.The surgeon was using the cork screw persuader as per the ifu.There was a significant surgical delay of approximately 45 minutes because the screw and rod needed to be replaced.The customer further reported that the case was an l5/s1 correction for a grade 2 spondylolisthesis with posterior decompression and expandible cage.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM
• 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: 5666465
• Report Number: 3005525032-2016-00057
• Device Sequence Number: 292925
• Product Code: MNH
• UDI-Device Identifier: 04546540562357
• UDI-Public: (01)04546540562357
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2016

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 Catalogue Number: 482317545
• Device Lot Number: B51458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2016
• Supplement Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR