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	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved pedicle screw, its set screw, and the broken tulip arrived for investigation; they were examined under a microscope.The examination indicated there were signs of damage attributed to cross-threading of the set screw in the tulip and hammering on the set screw.This indicates that the surgeon used high force to lock down the set screw down to the tulip (without a counter torque), which all contributed to the reported breakage.When the counter torque is positioned on the screw, it protects the tulip 360° and such breakage is not possible.It is therefore concluded that the breakage of the tulip was related to surgeon error; the surgeon did not follow the surgical technique or standard surgical practice.This circumstance is not related to a manufacturing or design problem.
Event or Problem Description
During an implantation of the tops system in the us, the surgeon used a mallet to hammer on the torque limiter connected to the pedicle screw and then performed a final tightening without the counter torque.During the final tightening, a portion of the pedicle screw tulip broke off.The surgeon indicated to the company's representative during the surgery that his incision was too small to use the counter torque.An adequate midline incision is required to perform the entire procedure correctly, including placing the counter torque, as described in the product labeling.The involved screw was removed and replaced with same size screw.

• 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: 20490903
• Report Number: 3012401682-2024-00010
• Device Sequence Number: 3506783
• Product Code: NKB
• UDI-Device Identifier: 07290115933895
• UDI-Public: 07290115933895
• 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
• Report Date (Section B): 10/21/2024

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: 88689
• Device Lot Number: CTPS0261
• 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: 09/24/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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