MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X45 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482616545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a xia serrato screw broke the pedicle upon implantation into l2 intra-operatively. no device specific issues were reported.The procedure was completed successfully without surgical delay.There were no adverse consequences nor medical intervention.
Additional Manufacturer Narrative
Device is implanted in the patient.
Event or Problem Description
It was reported that a xia serrato screw broke the pedicle upon implantation into l2 intra-operatively. no device specific issues were reported.The procedure was completed successfully without surgical delay.There were no adverse consequences nor medical intervention.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Initial report states that upon implantation of a serrato pedicle screw into the left l2 pedicle, the screw broke the pedicle.This bone damage intra-operatively was not confirmed.The x-ray provided was reviewed by clinical expert that could not identify the fracture of the left l2 pedicle.The device was implanted in the patient.No additional information was received regarding the product, procedure, patient, or event.Serrato surgical technique was reviewed: ¿intraoperative fissure, fracture, or perforation of the spine can occur due to implantation of the components.For increased bone purchase, use the taps to prepare the pedicle canal.After attaching a xia 3 handle, insert the tap into the pedicle and into the vertebral body.With the pedicle pathway prepared, and the proper screw diameter and length determined, insert the screw into the pedicle using the appropriate screwdriver.The serrato polyaxial titanium self-tapping screws have serrations to ease screw insertion.However, in most cases, tapping is recommended.¿ due to no additional information received regarding the patient or procedure a root cause could not be determined.
Event or Problem Description
It was reported that a xia serrato screw broke the pedicle upon implantation into l2 intra-operatively. no device specific issues were reported.The procedure was completed successfully without surgical delay.There were no adverse consequences nor medical intervention.

• Brand Name: 6.5X45 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; SZ 2300
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13311060
• Report Number: 3005525032-2022-00003
• Device Sequence Number: 12006427
• Product Code: NKB
• UDI-Device Identifier: 07613327352658
• UDI-Public: 07613327352658
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 482616545
• Device Catalogue Number: 482616545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male