inforMED — FDA medical device performance lookup

Device

Generic name

Idys-alif Plate H14mm

Manufacturer

Clariance Sas

Model number

24430014-S

Catalog number

24430014-S

Lot number

N339X-N317Y

Product problems

Difficult to Insert
Difficult to Insert

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

SURGEON COULDN'T GET SCREW TO LOCK INTO PLATE DURING IMPLANTATION. UPON INSPECTION, THE LOCKING RING LOOKED FINE AND NOT DAMAGED AT ALL TO SURGEON. THE SURGEON OPTED TO NOT SWAP OUT THE PLATE AND JUST USE THREE SCREWS. HE CLEARED THE PLATE/SCREW INTERFACE AREA OF ANY DEBRIS AND THE SCREW STILL WOULDN'T LOCK. AT THIS POINT, IT WAS ADJUDGED BY THE SURGEON TO PROCEED WITH THREE SCREWS.

Additional Manufacturer Narrative

3 SCREWS WERE USED NORMALLY WITHOUT PROBLEM. THE SURGEON WAS UNABLE TO PROPERLY LOCK THE FOURTH SCREW INTO THE PLATE. THE SURGEON OPTED TO NOT SWAP OUT THE PLATE AND JUST USED 3 SCREWS. ACCORDINGLY, THIS EVENT IS REPORTABLE AS A MALFUNCTION. (B)(6) 2024 - THE PLATE USED WAS CONFORMING TO CLARIANCE'S SPECIFICATION (CONTROL REPORT AND RAW MATERIAL CERTIFICATES). ANALYSIS ON THE PARTS WAS NOT POSSIBLE, AS IT WAS NOT EXPLANTED FROM THE PATIENT. CLARIANCE'S TEAM WAS ABLE TO REPRODUCE THE EVENT WHERE THE SLEEVE WAS NOT FIRMLY TIGHTENED WHILE THE SCREW WAS FULLY INSERTED. SAME DIFFICULTY WITH THE SCREW REMOVAL WAS OBSERVED. HOWEVER, WITH THE USE OF THE PROVIDED COUNTER TORQUE, AND T20 TIGHTENING KEY, UNTIGHTENING OF THE SCREW WAS MADE POSSIBLE WITHOUT ISSUE. TWO HYPOTHESES WERE MADE, ONE REGARDING THE CONDITION IN WHICH THE SURGEON TRIED TO REMOVE THE DEVICE, WITH LACK OF VISIBILITY AND PRESENCE OF TISSUES CONFLICTING WITH THE USE OF THE COUNTER TORQUE, AND ONE WITH THE METHOD USED.