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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: XTANT MEDICAL AXLE INTERSPINOUS FUSION SYSTEM PLIERS ALL-IN-ONE, INSERTER/COMPRESSOR, ASSEMBLY

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XTANT MEDICAL AXLE INTERSPINOUS FUSION SYSTEM PLIERS ALL-IN-ONE, INSERTER/COMPRESSOR, ASSEMBLY Back to Search Results
Model Number X060-1520
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2020
Event Type  Malfunction  
Manufacturer Narrative

The company received notification on (b)(6) 2020 that a surgical instrument had a malfunction during a surgical procedure. It was reported that the distal end of a system inserter/compressor fractured when being used to compress implant plates. There were no known patient complications associated with this complaint. There was an alternate instrument available, which was used to successfully complete the procedure. A visual assessment of the returned inserter/compressor showed an instrument with repeated use, as identified by surface scratches, worn laser markings, and minor surface staining. The handle a tip was broken from the body of the instrument. The metal cylinder at the proximal end of the handle a tip was sheared off, leaving a portion of the fractured cylinder within the handle a main body. A functionality assessment could not be performed due to the broken condition of the instrument. A dhr review was performed for the complaint lot and the devices met all required specifications prior to being released to distributable inventory. This lot has been available for distribution since 12/19/18. It may be possible that application of excessive compression force may have contributed to the handle a tip fracturing from the instrument. The handle a tip is secured into the body of the instrument with a cylinder that has minor movement to allow for implant engagement. It may be possible that over compressing the instrument may concentrate applied force to the handle a tip, resulting in an instrument malfunction.

 
Event Description

The company received notification on (b)(6) 2020 that a surgical instrument had a malfunction during a surgical procedure. It was reported that the distal end of a system inserter/compressor fractured when being used to compress implant plates. There were no known patient complications associated with this complaint. There was an alternate instrument available, which was used to successfully complete the procedure.

 
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Brand NameAXLE INTERSPINOUS FUSION SYSTEM
Type of DevicePLIERS ALL-IN-ONE, INSERTER/COMPRESSOR, ASSEMBLY
Manufacturer (Section D)
XTANT MEDICAL
664 cruiser lane
belgrade, mt
Manufacturer (Section G)
XTANT MEDICAL
664 cruiser lane
belgrade, mt
Manufacturer Contact
rebecca lennemann
664 cruiser lane
belgrade, mt 
3880480112
MDR Report Key10289073
MDR Text Key208791048
Report Number3005031160-2020-00017
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2020
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberX060-1520
Device LOT Number10675
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/02/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/17/2020 Patient Sequence Number: 1
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