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

Catalog Number	482317580
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	01/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; on (b)(6) 2016, the patient underwent the surgery.The surgeon confirmed x-ray.And he found that the screw head separated from the screw shaft(s2ai).Therefore, the patient underwent the revision surgery on (b)(6) 2017.
Additional Manufacturer Narrative
Method: visual inspection;device history review; complaint history review; risk assessment; results: no relevant manufacturing issues were identified as all units met stryker specifications.Tulip disengagement was confirmed via visual inspection.Conclusion: due to the multi-factorial nature of the event, and lack of patient/initial procedure information, a definite root cause cannot be determined.
Event or Problem Description
It was reported that; on (b)(6) 2016, the patient underwent the surgery.The surgeon confirmed x-ray.And he found that the screw head separated from the screw shaft(s2ai).Therefore, the patient underwent the revision surgery on (b)(6) 2017.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 80 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: 6358191
• Report Number: 3005525032-2017-00020
• Device Sequence Number: 16152399
• Product Code: MNI
• UDI-Device Identifier: 04546540562401
• UDI-Public: (01)04546540562401
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: 482317580
• Device Lot Number: B56905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 05/24/2017
• 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
• Patient Age: 66 YR