MAUDE Adverse Event Report: STRYKER SPINE-US 7.5X50 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482617550
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital disposed of device.
Event or Problem Description
It was reported that the patient was implanted with posterior fixation from t12 to l3.Approximately one year after initial surgery, it was observed that the xia polyaxial screw at l3 had "loosened".The patient was revised to remove the reported screw.
Event or Problem Description
It was reported that the patient was implanted with posterior fixation from t12 to l3.Approximately one year after initial surgery, it was observed that the xia polyaxial screw at l3 had "loosened".The patient was revised to remove the reported screw.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was scrapped by customer.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.Initial surgery was performed on (b)(6) 2020 patient was implanted with posterior fixation from t12 to l3.Approximately one year after initial surgery, it was observed that the xia serrato polyaxial screw at l3 had "loosened".The patient was revised to remove the reported screw on (b)(6) 2021.Additional information was requested related to the event.However, no additional information was received.It is unknown if the patient fused.Patient's bone quality and post-op activity level/ external trauma are unknown.No information on the initial surgery/ operative notes/ x-rays are available.The xia device ifu and surgical technique were reviewed: these implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.Improper selection, placement, positioning and fixation of these devices may result in unusual stress conditions reducing the service life of the implant.Postoperative care and the patient¿s ability and willingness to follow instructions are two of the most important aspects of successful healing.Due to lack of information and as the device was not returned, an exact cause of the reported event could not be determined.Potential causes include: excess patient activity level, non fusion due to patient's bone quality and inadequate construct compression during initial surgery.

• Brand Name: 7.5X50 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: 12628185
• Report Number: 3005525032-2021-00044
• Device Sequence Number: 3451953
• Product Code: NKB
• UDI-Device Identifier: 07613327352641
• UDI-Public: 07613327352641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 482617550
• Device Catalogue Number: 482617550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 01/25/2022
• 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: Required Intervention
• Patient Sex: Male
• Patient Race: Asian