MAUDE Adverse Event Report: XTANT MEDICAL CALIX LUMBAR SPINAL IMPLANT SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	X034-0015
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned inserter showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The threaded portion of the inserter rod was fractured, and the broken piece was not returned.There were rotational scratches identified along the length of the instrument.A functionality assessment could not be performed due to the instrument malfunction, which prevented it from functioning as intended.A dhr review was performed for the returned device lot, which met all required specifications prior to being initially released to distributable inventory.It was reported that the distal tip of the inserter broke off in an implant while being placed during a procedure.If the inserter was shifted while the implant maintained a fixed position, it may result in the distal tip of the inserter breaking.The distal tip of the inserter rod is threaded, which is used to engage the threading of the implant.If the inserter was shifted after the implant has been placed, the lateral force applied is concentrated to the threaded interface of the instrument and implant.The concentration of lateral force may result in the threaded portion the inserter breaking.The complaint investigation suggests the possibility that the inserter was shifted after the implant was placed, resulting in a malfunction at the distal tip of the inserter.
Event or Problem Description
The company received notification on (b)(6) 2020 regarding an instrument malfunction that occurred during a surgical procedure.It was reported that the threaded distal tip of a system inserter fractured inside of an implant when being placed.The implant with the fractured distal tip of the inserter was removed and replaced with another implant.There was an alternate inserter available, which was used to successfully complete the procedure.There were no known patient complications associated with this instrument malfunction.

• Brand Name: CALIX LUMBAR SPINAL IMPLANT SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 10829704
• Report Number: 3005031160-2020-00028
• Device Sequence Number: 14180181
• Product Code: MAX
• UDI-Device Identifier: M697X03400151
• UDI-Public: M697X03400151
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K170119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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: X034-0015
• Device Lot Number: 760901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/12/2020
• 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: 73 YR
• Patient Weight: 92