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Model Number X060-0080
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2021
Event Type  malfunction  
Manufacturer Narrative
A visual assessment of the returned implant construct showed devices that had extensive surface scratches surrounding the plates. The crossbar insert was identified as damaged, with scratches present on the exposed end of the insert. The proximal opening of the threading on the locking plate was damaged and approximately half of the fractured set screw was present in the locking plate. The proximal portion of the locking plate set screw was fractured with some threading peeling away. Spikes on both the cross bar plate and locking plate were damaged and not sharp as intended. There was a rotational impact mark present on the cross bar and insert where the set screw was tightened to secure the implant construct. The placement of the set screw impact mark indicates the plates were not adequately compressed to allow for the set screw to sit on the flat portion of the cross bar prior to final tightening of the set screw. A functionality assessment was not performed because implants are intended for single use only, and explanted devices are discarded per procedure. A dhr review was performed for complaint lot# 11972 and there were no manufacturing anomalies identified. The device met all required specifications prior to being released to distributable inventory. This lot has been available for distribution since 11/19/2018. The system surgical technique guide step 3: implant insertion states, "once loaded, lower the instrument into the interspinous space and confirm placement via fluoroscopy. " also, in the surgical technique guide, step 8: compression of plate states, "prior to applying compression, take a lateral x-ray to confirm proper positioning. " the intraoperative management section of the system ifu provides guidance on confirming implant placement and states, "whenever possible or necessary, an imaging system should be utilized to facilitate surgery. " the complaint details provided, and photos taken at the manufacturer were discussed with a subject matter expert to provide input on the reported implant malfunction. The assessment of the reported implant deficiency was that the system plates had not been compressed enough for the set screw to be tightened flat on the cross bar of the implant. If an interspinous plate construct was not adequately compressed, the cross bar would not be in the correct position for the set screw to be tightened flat. The rotational force applied to an uneven surface may allow the distal portion of the set screw to pull apart within the threading of the locking plate, and not identified until the set screw was being loosened to adjust implant position. There have not been any other complaints of similar nature in the past 12 months. The company will continue to monitor this device for complaints from the field.
Event Description
The company was notified on 9/28/2021 of an implant malfunction that occurred after placing an interspinous plate construct. After implant placement, the physician elected to make a position adjustment of the implants. When the set screw of a locking plate assembly was being loosened, it sheared off. The implant construct was removed and successfully replaced with alternate implants without any further issues. There were no known patient complications associated with this complaint. The complaint device arrived at the manufacturer for assessment on 10/01/2021.
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Manufacturer (Section D)
664 cruiser lane
belgrade MT 59714
Manufacturer (Section G)
664 cruiser lane
belgrade MT 59714
Manufacturer Contact
rebecca lennemann
664 cruiser lane
belgrade, MT 59714
MDR Report Key12668531
MDR Text Key277946224
Report Number3005031160-2021-00022
Device Sequence Number1
Product Code PEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberX060-0080
Device Lot Number11972
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/20/2021 Patient Sequence Number: 1