MAUDE Adverse Event Report: ALPHATEC SPINE, INC OSSEOSCREW; OSSEOSCREW F TI HIGH TOP 6.5 X 50MM

Model Number	53165-50; 53165-50
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
After removing a screw, the surgeon was unable to decompress the expansion area because the tulip was locked in place.
Additional Manufacturer Narrative
H6: problem code:2017 component code: 568 type of investigation: 3331; 10 investigation findings: 4248 investigations conclusions: 18 h10: visual inspection of both osseoscrew's confirms the event.The expansion region was not collapsed on either screw.The reported event states the surgeon used a regular osseoscrew driver to remove the screws.The surgical technique guide indicates osseoscrew retrieval tool (pn 54900-30) is to be used to engage and remove the distal tip of the screw remaining in the vertebral body.The tool is used to advance the distal tip of the osseoscrew anteriorly; this will collapse the expansion region.The surgeon is to confirm the distal tip is collapsed using lateral fluoro images.Once the expansion region is collapsed, rotate counterclockwise and proceed to back the distal tip out.Based on information provided, the surgical technique guide was not followed.Labeling review: 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.

• Brand Name: OSSEOSCREW
• Common Device Name: OSSEOSCREW F TI HIGH TOP 6.5 X 50MM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: alaba ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946771
• MDR Report Key: 12255865
• Report Number: 2027467-2021-00053
• Device Sequence Number: 3635417
• Product Code: NKB
• UDI-Device Identifier: 00844856049062
• UDI-Public: 00844856049062
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 06/30/2021

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?: No
• Device Model Number: 53165-50; 53165-50
• Device Lot Number: 650666; 718434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male