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

Model Number	C003-0028
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 a rasp broke off the handle while the surgeon was removing the rasp from the patient.There was a slight surgical delay while the surgeon successfully removed the rasp from the patient.There were no known patient complications.The rasp was returned for complaint assessment.The instrument had signs of repeated use.The damage was present as described by the complainant.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to being released for distribution.
Event or Problem Description
The complainant reported that a rasp broke off the handle while the surgeon was removing the rasp from the patient.The surgeon successfully removed the rasp and 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: 8262753
• Report Number: 3005031160-2019-00003
• Device Sequence Number: 2370881
• Product Code: ODP
• UDI-Device Identifier: M697C00300281
• UDI-Public: M697C00300281
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 01/18/2019

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: C003-0028
• Device Lot Number: SPE1893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/18/2019
• 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: Other