MAUDE Adverse Event Report: ALPHATEC SPINE INC SD - PEEK SMALL SPACER - 9 MM X 22 MM X 8 MM (PEEK); NOVEL VBR SPINAL SYSTEM

Model Number	64813-008
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records found no manufacturing, processing or design related irregularities.The peek cage was found to be properly manufactured and released in accordance with the device master record.Visual inspection found the implant had fractured and broke into 4 separate sections.The breakage appears to have started at the side id threads where the inserter instrument attaches to the implant.Based on both the report and the visual evidence, it appears the failure was likely caused by an inappropriate sized implant to disk space.Alphatec provides trials with each instrument set to determine the correct size implant.The height of the implant is measured at the center of the bi-convex implant, and is inclusive of the teeth.The corresponding trial is sized to match the implant with the teeth.The novel spinal spacer system is an intervertebral body fusion device that can also be used as a vertebral replacement device.The implants are a spinal fixation system consisting of various cylindrical shapes (footprints) of varying lengths, widths and heights to accommodate individual patient pathology.System implants are manufactured of surgical grade titanium alloy (astm f-136) or polyetheretherketone, peek (astm f-2026).A radiographic marker made of titanium (astm f-136) or tantalum (astm f-560) facilitates visualization.The novel spinal system must be used with a supplemental spinal fixation system.
Event or Problem Description
During a tilf of the l5/s a novel peek cage broke while inserting.Because the interbody of the patient was narrow, the surgeon hit the cage with the hammer a few times and found the cage had broken into the pieces.The incident caused one hour delay of the case.The surgeon could not recover all the pieces of the broken cage, so some fragments remain within the patient.

• Brand Name: SD - PEEK SMALL SPACER - 9 MM X 22 MM X 8 MM (PEEK)
• Common Device Name: NOVEL VBR SPINAL SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8932369
• Report Number: 2027467-2019-00041
• Device Sequence Number: 2207054
• Product Code: MQP
• UDI-Device Identifier: 00844856019294
• UDI-Public: (01)00844856019294(10)687466
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

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
• Operator of Device: Health Professional
• Device Model Number: 64813-008
• Device Catalogue Number: 64813-008
• Device Lot Number: 687466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/26/2019
• 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: Hospitalization
• Patient Age: 77 YR