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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 09/21/2021
Event Type  malfunction  
Manufacturer Narrative
A visual assessment of the returned complaint inserter/compressor showed an instrument with minimal use, as identified by crisp laser markings and a lack of surface scratches. The pin of the instrument distal tip was fractured where it connects with the instrument handle. A functionality assessment was not performed due to the damaged condition of the returned inserter/compressor, which was removed from distributable inventory. It may be possible that application of excessive compression force may have contributed to one of the instrument distal tips fracturing from the instrument. The instrument tip is secured into the instrument handle with a cylinder that has minor movement to allow for implant engagement and patient anatomy. It may be possible that plate angulation due to patient anatomy or over compressing the instrument may concentrate applied force to the instrument distal tip, resulting in an instrument malfunction.
 
Event Description
The company received notification on (b)(6) 2021 of a system inserter/compressor that malfunctioned during a surgical procedure. It was reported that one of the distal tips of the instrument fractured while compressing interspinous plates after being placed. There were no known patient complications associated with this complaint. Alternate available instruments were used to successfully complete the surgical procedure. The complaint instrument arrived at the manufacturer for assessment on 9/28/2021.
 
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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 Key12586780
MDR Text Key275170819
Report Number3005031160-2021-00021
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 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberX060-1520
Device Lot Number21179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2021
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: 10/06/2021 Patient Sequence Number: 1
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