MAUDE Adverse Event Report: ALPHATEC SPINE INC OSSEOSCREW SPINAL FIXATION SYSTEM; ORTHOSIS, SPINE PEDICLE FIXATION

Model Number	53065-40
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The implant was not removed from the patient.The indications for use as stated in ins-101; the osseoscrew system (for use with the zodiac spinal fixation system and illico mis posterior fixation system) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.Warnings 5.Once the osseoscrew implant has been deployed, it may be difficult to un-deploy, re-position, or remove; therefore, it is important to confirm proper placement of the osseoscrew prior to deploying the expansion feature by use of fluoroscopy or other suitable imaging technique.
Event or Problem Description
On (b)(6) 2021 revision surgery was conducted removing a previously implanted construct in order to perform an osteotomy.During the screw removal, the distal expansion section of the osseoscrew fracture and broke.The detached section remaining entrapped within the patients right l5.The osseoscrew spinal fixation system was originally implanted (b)(6) 2020.

• Brand Name: OSSEOSCREW SPINAL FIXATION SYSTEM
• Common Device Name: ORTHOSIS, SPINE PEDICLE FIXATION
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 11372314
• Report Number: 2027467-2021-00004
• Device Sequence Number: 4711375
• Product Code: NKB
• UDI-Device Identifier: 00844856049123
• UDI-Public: (01)00844856049123
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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: 53065-40
• Device Catalogue Number: 53065-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/24/2021
• 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: Other