inforMED
MalfunctionKWP

SEE H10

Received Jul 7, 2026

Report 3012447612-2026-00160 · MDR key 25734549

Device

Generic name

Appliance, Fixation, Spinal Interlaminal

Model number

NA

Catalog number

SEEH10

Lot number

NI

Product problems

  • Fracture

Patient

NA · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

D1: POLYAXIAL SCREW (Ø3.5MM X 18MM L) OR (Ø3.5MM X 14MM L) OR (Ø5.5MM X 25MM L) OR (Ø5.5MM X 30MM L) D4: CATALOG NUMBER: 07.01702.011 OR 07.01702.007 OR 07.01708.019 OR 07.01708.020 D4: UDI NUMBER: THE UDI NUMBER IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS ARE NOT AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING IMAGING TAKEN A LITTLE OVER A MONTH AND A HALF POST-OP, A SCREW WAS OBSERVED TO HAVE FRACTURED SUCH THAT IT "LOOKS LIKE IT EXPLODED". A REVISION SURGERY HAS NOT YET BEEN SCHEDULED AND THE PATIENT IS NOT EXPERIENCING ANY COMPLICATIONS.