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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: XTANT MEDICAL AXLE INTERSPINOUS FUSION SYSTEM SPINOUS PROCESS PLATE

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XTANT MEDICAL AXLE INTERSPINOUS FUSION SYSTEM SPINOUS PROCESS PLATE Back to Search Results
Model Number X060-1520
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
The system implant plate is secured to the inserter/compressor by tightening a set screw on the instrument. It may be possible to fracture the distal tip of an inserter/compressor if excessive force was applied to the interface between the inserter/compressor and implant plate by over tightening the set screw. The root cause of this complaint cannot be reliably determined due to a lack of available information. The complaint investigation suggests the possibility that the set screw that secures the implant plate to the inserter/compressor was over tightened, resulting in the distal portion of the instrument breaking.
 
Event Description
The company received notification on (b)(6) 2021 of a system inserter/compressor that was reported to malfunction when loading an implant onto the instrument. Five attempts to gather relevant complaint incident information and request the instrument to be returned were made, and no additional information was provided. There were no known patient complications reported as part of this instrument complaint. The instrument has not been received at the manufacturer for complaint assessment.
 
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Brand NameAXLE INTERSPINOUS FUSION SYSTEM
Type of DeviceSPINOUS PROCESS PLATE
Manufacturer (Section D)
XTANT MEDICAL
664 cruiser lane
belgrade MT 59714
Manufacturer (Section G)
XTANT MEDICAL
664 cruiser lane
belgrade MT 59714
Manufacturer Contact
rebecca lennemann
664 cruiser lane
belgrade, MT 59714
MDR Report Key12510841
MDR Text Key272680150
Report Number3005031160-2021-00018
Device Sequence Number1
Product Code PEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberX060-1520
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/21/2021 Patient Sequence Number: 1
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