MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. CALIX SPINAL IMPLANT SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	X034-0015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that two inserters failed in the field.The malfunction was discovered prior to implantation during a surgery.An alternate instrument was available to complete the procedure.There were no known patient complications.The broken inserter was returned for evaluation where it was confirmed that the distal portion of the threaded post used to hold trials and implants was broken off.The damage to the inserter could be replicated by applying lateral force to the implant/trial while not fully engaged with the threaded post of the inserter.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior lot release.This lot has been available for distribution since 10/30/2012.
Event or Problem Description
The complainant reported that two inserters failed in the field.The malfunction was discovered prior to implantation during a surgery.An alternate instrument was available to complete the procedure.There were no known patient complications.

• Brand Name: CALIX SPINAL IMPLANT SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 7940494
• Report Number: 3005031160-2018-00029
• Device Sequence Number: 930883
• Product Code: ODP
• UDI-Device Identifier: M697X03400151
• UDI-Public: M697X03400151
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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: I6345-0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/05/2018
• 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