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	08/20/2024
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 into the tulip.This indicates that the surgeon used high force to insert the set screw all the way down the tulip, instead of unscrewing the set screw and placing it correctly before trying to tighten it, which is the accepted practice in this case.This resulted in the reported breakage.Moreover, as indicated in the event description, the reported breakage could only happen 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 related to surgeon error; the surgeon did not follow the surgical technique and standard practice in spine surgeries.This circumstance is not related to a manufacturing or design problem.
Event or Problem Description
The company received a report that a pedicle screw tulip broke during a surgical procedure.Following pedicle screw insertion, set screws were placed in tulips.The surgeon stood on patient's right side and assembled counter-torque and torque limiter on the nearest tulip, sliding counter-torque up to visualize the torque limiter's distal tip.Attempts to place torque limiter tip into l4 right set screw were difficult.A mallet was used to hammer the handle of torque limiter to deepen the tip into the set screw.Depth of tip could not be confirmed after malleting.When the final tightener was turned on first set screw, a loud pop was heard in conjunction with the set screw flying across room and the sidewall of tulip laying on operating table.The surgeon was leaning back during the tightening process.This circumstance could only happen if the counter torque was not locked on the rod and seated over the tulip during the tightening process.The l4 right screw was removed and replaced with same size screw (7.5x55mm).Fusion rods and set screws were placed and the set screw inserter was used to tighten the set screws.

• 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: 20240505
• Report Number: 3012401682-2024-00009
• Device Sequence Number: 18183554
• Product Code: NKB
• UDI-Device Identifier: 07290115933918
• UDI-Public: 07290115933918
• 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): 09/17/2024

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: 88691
• Device Lot Number: CTPS028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2023
• 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 Age: 64 YR
• Patient Sex: Male