MAUDE Adverse Event Report: PREMIA SPINE LTD. PEDICLE SCREW; SPINAL IMPLANT

Model Number	PEDICLE SCREW
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an implantation of the tops system in the us, during the final tightening, a portion of the pedicle screw tulip broke off.The surgeon removed the setscrews and broken screws, inserted a new 6.5mm screw.All setscrews were successfully tightened with no further issues.
Additional Manufacturer Narrative
Review of the manufacturing records of the involved lots was performed and indicated that they were manufactured in accordance with company specifications.At this time, the pedicle screws have not yet been received for investigation.When the screws are returned, an investigation will be carried out and a follow-up report will be submitted.
Event or Problem Description
During an implantation of the tops system in the us, during the final tightening, a portion of the pedicle screw tulip broke off.The surgeon removed the setscrews and broken screw and inserted a new 6.5mm screw.All setscrews were successfully tightened with no further issues.
Additional Manufacturer Narrative
The involved pedicle screws, set screws, and tulips arrived for investigation; they were examined under a microscope.The examination indicated signs of damage attributed to cross-threading of the set screw into the tulip and signs of hammering with an external tool.This indicates that the surgeon forced the set screw all the way down the tulip, instead of unscrewing the set screw and placing it correctly before tightening, which is the standard practice in case of cross-threading.This resulted in the reported breakage.Moreover, such breakage can happen only if the counter torque was not seated down over the tulip and locked on rod during the tightening process, as required.When the counter torque is properly positioned, it protects the tulip 360° and such breakage is not possible.It is therefore concluded that the breakage of the tulip was not related to a manufacturing or design problem but related to use error; the surgeon did not follow the surgical technique and standard practice in spine surgeries.

• Brand Name: PEDICLE SCREW
• Common Device Name: SPINAL IMPLANT
• Manufacturer (Section D): PREMIA SPINE LTD.; 7 giborey israel st.; ramat poleg; netanya, 42504 07; IS 4250407
• Manufacturer (Section G): PREMIA SPINE LTD.; 7 giborey israel st.; ramat poleg; netanya, 42504 07; IS 4250407
• Manufacturer Contact: elinor limor ; 7 giborey israel st.; ramat poleg; netanya, 42504-07 ; IS 4250407
• MDR Report Key: 21101948
• Report Number: 3012401682-2025-00001
• Device Sequence Number: 8629667
• Product Code: NKB
• UDI-Device Identifier: 07290115933741
• UDI-Public: 07290115933741
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2025

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: Health Professional
• Device Model Number: PEDICLE SCREW
• Device Catalogue Number: 88674
• Device Lot Number: CTPS014A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown