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

Model Number	53065-40
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The remainder implant has not been returned.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
The tip of an osseoscrew broke off while removing it during a revision surgery.The detached section was unable to be removed from the patient.
Additional Manufacturer Narrative
The initial submission 2027467-2021-00012 was erroneously submitted on 03/25/2021.After further investigation, it was determined this was a duplicate submission to 2027467-2021-00004 which was filed with the fda on 02/24/2021.

• Brand Name: OSSEOSCREW SPINAL FIXATION SYSTEM
• Common Device Name: ORTHOSIS, SPINE PEDICLE FIXATION
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11569310
• Report Number: 2027467-2021-00012
• Device Sequence Number: 19656153
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 07/15/2021
• 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
• Patient Age: 57 YR