MAUDE Adverse Event Report: ALPHATEC SPINE INC TI CANNULATED POLYAXIAL SCREW 7.5 MM X 40 MM (TI-6AI-4V ELI); PEDICLE SCREW SYSTEM

Model Number	73875-40
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review if the device history records revealed no manufacturing or processing related irregularities.The instrument was found to be properly manufactured and released in accordance with design specifications.Visual examination found one side of the tulip has been completely broken/detached from the remainder of the implant.
Event or Problem Description
The surgeon tried to remove the screw extender from the screw using the recommended remover tool, but was unsuccessful.He then attempted removal via the removal aid tool and heard a breaking sound.He found that the screw head/tulip had broken.Removed and replacement of the screw caused an hour delay in the case.

• Brand Name: TI CANNULATED POLYAXIAL SCREW 7.5 MM X 40 MM (TI-6AI-4V ELI)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8974885
• Report Number: 2027467-2019-00042
• Device Sequence Number: 10846542
• Product Code: NKB
• UDI-Device Identifier: 00844856043329
• UDI-Public: (01)00844856043329(10)715033
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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: 73875-40
• Device Catalogue Number: 73875-40
• Device Lot Number: 715033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/09/2019
• 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
• Patient Age: 47 YR