MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW CLOSED HEAD 7.5 X 80MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482377580
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2013, the patient underwent the surgery.On (b)(6) 2016, the surgeon confirmed x-ray and found that the screw head was broken off.Therefore, the surgeon is planning a revision surgery on (b)(6) 2016.It's being fixed in (b)(6) 2015 from a upper thoracic vertebra to the mid lumber vertebra, but the implants isn't connected with fixing in 2013.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: deformation of the screw head and retaining clip was observed on the returned device.This deformation was likely due to repeated stresses placed on the screw.The ifu states that these implants cannot be expected to indefinitely withstand the activity level and normal load of healthy bones.These implants are meant to provide fixation and some temporary support during fusion of the vertebrae.It was stated that the implants were implanted in 2013, and that the patient did not fuse, meaning the construct was tasked with bearing the load of the spine for this prolonged amount of time.Conclusion: the most likely cause of the customer reported event is non-union of the patient.
Event or Problem Description
It was reported that on (b)(6) 2013, the patient underwent the surgery.On (b)(6) 2016, the surgeon confirmed x-ray and found that the screw head was broken off.Therefore, the surgeon is planning a revision surgery on (b)(6) 2016.It's being fixed in (b)(6) 2015 from a upper thoracic vertebra to the mid lumber vertebra, but the implants isn't connected with fixing in 2013.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW CLOSED HEAD 7.5 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: 5486422
• Report Number: 3005525032-2016-00023
• Device Sequence Number: 405176
• Product Code: MNH
• UDI-Device Identifier: 07613327003093
• UDI-Public: 07613327003093
• Combination Product (Y/N): N
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2016

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
• Operator of Device: No Information
• Device Catalogue Number: 482377580
• Device Lot Number: B30094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 07/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention