MAUDE Adverse Event Report: ALPHATEC SPINE INC ARSENAL SPINAL FIXATION SYSTEM; PEDICLE SCREW SYSTEM

Model Number 47127

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

A review of the device history records did not identify any manufacturing or processing relate irregularities.The set screw was found to be properly manufactured and released in accordance with design specifications.

Event Description

On (b)(6) 2021 it was found the set screw in the pedicle screw implanted at l4 was loosened and the rod came out of the tulip of the screw post surgery.A revision surgery was conducted on (b)(6) 2021 to remove and replace the construct.The arsenal spinal fixation system was implanted on (b)(6) 2021.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604319286
• MDR Report Key: 11682737
• MDR Text Key: 245976237
• Report Number: 2027467-2021-00016
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582(10)8185401
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 8185401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR