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

Model Number	16183-050
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The instruments have not been returned nor has the identifying lot number(s) been provided.
Event or Problem Description
Two invictus osseoscrew expansion shafts broke during expansion.One broke at the distal threads, the other broke before the distal threads and at the proximal end.
Additional Manufacturer Narrative
The invictus¿ osseoscrew® 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.Osseoscrew are screws, that are expandable.And an expansion shaft is used to expand the screws.The expansion handle included in the system provides a controlled amount of distance to pull an expansion shaft.As the expansion shaft is pulled, the osseoscrew expands.This function creates tension on the expansion shaft as the osseoscrew is being expanded.Although the products were not returned for evaluation.No lot numbers provided.Pictures were provided by email to assist in the evaluation.The complaint reported, the expansion shafts broke, while attempting to expand the osseoscrew.And the screws did not expand.Investigation conducted by the project engineer, determined that this particular occurrence was the result of expansion forces.That exceed the expansion shaft tensile strength and lead to expansion shaft breakage.A broken piece of expansion shaft remains entrapped in the osseoscrew implanted in the patient.The expansion shafts are made of stainless steel 465.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11568350
• Report Number: 2027467-2021-00010
• Device Sequence Number: 3521172
• Product Code: NKB
• UDI-Device Identifier: 00190376307329
• UDI-Public: (01)00190376307329
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 16183-050
• Device Catalogue Number: 16183-050
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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: 51 YR