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

Model Number	Ø6.5X55MM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved pedicle screw and tulip were examined under a microscope.The examination indicated signs of damage attributed to cross-threading of the set screw into the tulip and hammering on the tulip.This indicates that the surgeon forced the set screw into the tulip, instead of unscrewing the set screw and placing it correctly, which is the standard practice in case of cross-threading.This resulted in the breakage of the tulip.It is therefore concluded that the breakage of the tulip was not related to a manufacturing or design problem but related to use error.
Event or Problem Description
A pedicle screw was returned with a broken tulip.No other details were provided and no additional information is available.

• 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: 22804554
• Report Number: 3012401682-2025-00010
• Device Sequence Number: 15665145
• Product Code: NKB
• UDI-Device Identifier: 07290115931938
• UDI-Public: 07290115931938
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: Ø6.5X55MM
• Device Catalogue Number: 88514
• Device Lot Number: NCPS013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2024
• 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
• Patient Sex: Unknown