MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 55 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482317555
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; implantation of screw (b)(4) in vertebral body s1, during revision surgery (b)(6) 2016 with enlargement spondylodeses cranial, inserting new side rail to vertebral body s1, screws remained in vertebral body.Actual broken screws were detected both-sided in s1.Clinical root cause most likely to pseudoarthroses l5/s1 due to not healed cage in spinal disk shelf l5/s1.Conspicuous is the break of screws both-sided.Both screws are from the same lot, the heads of screws were removed for exhibit, the broken screw rests remain in vertebral body; new screws were placed.Handling screws every time corresponding to manufacturers´ instructions.
Additional Manufacturer Narrative
Method:device history review; complaint history review; risk assessment; results: visual, dimensional and functional analysis could not be performed as the device was not returned.No relevant manufacturing issues were identified as all released units met specifications.Conclusion: a definite root cause could not be determined.However, it is likely that wear of the device contributed to the event.
Event or Problem Description
It was reported that; implantation of screw 2016-01-04 in vertebral body s1, during revision surgery (b)(6) 2016 with enlargement spondylodeses cranial, inserting new side rail to vertebral body s1, screws remained in vertebral body.Actual broken screws were detected both-sided in s1.Clinical root cause most likely to pseudoarthroses l5/s1 due to not healed cage in spinal disk shelf l5/s1.Conspicuous is the break of screws both-sided.Both screws are from the same lot, the heads of screws were removed for exhibit, the broken screw rests remain in vertebral body; new screws were placed.Handling screws every time corresponding to manufacturers´ instructions.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 55 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: 6367302
• Report Number: 3005525032-2017-00022
• Device Sequence Number: 19083071
• Product Code: MNI
• UDI-Device Identifier: 04546540562371
• UDI-Public: (01)04546540562371
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

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 Catalogue Number: 482317555
• Device Lot Number: B53665
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• Supplement Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR