MAUDE Adverse Event Report: ALPHATEC SPINE INC POLYAXIAL SCREW, 6.5 MM X 45 MM (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number	47000-065-045
Health Effect - Clinical Codes	Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned implants are currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Revision surgery was conducted to remove two polyaxial screws which were found to have broken.The screw shank fractured & broke towards the interface.The detached sections both remains implanted within the patients vertebrae.
Additional Manufacturer Narrative
Both returned polyaxial screw are of the same part & lot number.An evaluation of the first screw found that it had fractured at the neck of the shank.A review of the shank component (pn 47000-3-65-045) revealed that this is the material transition between the shank neck to the screw threads.Upon visual inspection, it is noted that the location of fracture is approximately at the transition.Therefore, the failure is attributed to shear of the shank at the neck diameter.The second polyaxial screw was found to be fractured within the threaded section of the screw shank.The evaluation of the component (pn 47000-3-65-045) found that this is the material transition from the neck to the minor diameter.This transition to the minor occurs at a distance "e", which per the print is 6mm from the base of the neck.Upon visual investigation, it is noted that the location of fracture is greater than 10mm.Therefore, the failure is attributed to shear of the shank the minor diameter.

• Brand Name: POLYAXIAL SCREW, 6.5 MM X 45 MM (TI-6AL-4V ELI)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 9135403
• Report Number: 2027467-2019-00046
• Device Sequence Number: 2233590
• Product Code: NKB
• UDI-Device Identifier: 00844856070745
• UDI-Public: (01)00844856070745(10)8046502
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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: 47000-065-045
• Device Catalogue Number: 47000-065-045
• Device Lot Number: 8046502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization