MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482316545
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; on (b)(6) 2015, the patient underwent the surgery.On (b)(6) 2016, the surgeon found through the mri image that the screw was broken (l4).Therefore the surgeon is monitoring for the patient now.The revision surgery is not planning now.
Additional Manufacturer Narrative
Lot# b40866.Method: device history review; complaint history review; risk assessment.Results: the device is still implanted so it was not returned.No manufacturing issues identified.Operative notes/medical history of the patient cannot be provided.Conclusion: without the device and further information regarding the patient, the root cause cannot be determined conclusively and is multifactorial.
Event or Problem Description
It was reported that on (b)(6) 2015, the patient underwent the surgery.On (b)(6) 2016, the surgeon found through the mri image that the screw was broken (l4).Therefore the surgeon is monitoring for the patient now.The revision surgery is not planning now.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 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: 5821738
• Report Number: 3005525032-2016-00088
• Device Sequence Number: 16254964
• Product Code: MNH
• UDI-Device Identifier: 04546540562241
• UDI-Public: (01)04546540562241
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2016

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: 482316545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 10/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 90