MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 35 MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482316535
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2014, the patient underwent the surgery with for th10-l1(plf).On (b)(6) 2016, the patient underwent the revision surgery for l2-3(plif).After surgery, when the surgeon checked x-ray, the screw broke.Therefore, the surgeon planning the revision surgery now.
Additional Manufacturer Narrative
Risk assessment; visual, dimensional and complaint history review could not be performed as the device was not returned and lot# was not provided.The definitive root cause of the event could not be determined from given information.
Event or Problem Description
It was reported that on (b)(6) 2014, the patient underwent the surgery with for th10-l1(plf).On (b)(6) 2016, the patient underwent the revision surgery for l2-3(plif).After surgery, when the surgeon checked x-ray, the screw broke.Therefore, the surgeon planning the revision surgery now.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 35 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: 6296255
• Report Number: 3005525032-2017-00015
• Device Sequence Number: 19024736
• Product Code: MNH
• UDI-Device Identifier: 04546540562227
• UDI-Public: (01)04546540562227
• Combination Product (Y/N): N
• PMA/510(K) Number: K071373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

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: 482316535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 05/30/2017
• 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: 62 YR
• Patient Weight: 63