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

Model Number 47127

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

No evaluation possible at this time.The international user facility has not returned the explanted set screws to (b)(4).Upon receipt of the device and/or additional information a follow up report will be submitted.

Event Description

Revision surgery was conducted on (b)(6) 2020 to remove & replace two arsenal set screws.Post-op images taken (b)(6) 2020 revealed both set screws located at the l3 had backed out of position.The arsenal spinal fixation system was implanted on (b)(6) 2020 at the t11-l3.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• Manufacturer Contact: richard younger ; 5818 el camino real; carlsbad, ca ; 4949286
• MDR Report Key: 10283253
• MDR Text Key: 199127473
• Report Number: 2027467-2020-00031
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582(10)8460801
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 8460801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 93 YR