inforMED
MalfunctionHBW

1.5X6MM HT SD X-DR SCR 5-PK

Received May 28, 2026 · Event occurred May 10, 2026

Report 0001032347-2026-00128 · MDR key 25317436

Device

Generic name

Fastener, Plate, Cranioplasty

Catalog number

95-6106

Lot number

SEE H11

Product problems

  • Fracture

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THE DURING INITIAL IMPLANTATION, TWO SCREWS FRACTURED WHILE THE SURGEON WAS ADJUSTING THEM TO THE PATIENT. THE PROCEDURE WAS SLIGHTLY DELAYED, BUT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY BY IMPLANTING ANOTHER SCREW. THERE WAS NO REPORTED PATIENT HARM OR INJURY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

Additional Manufacturer Narrative

(B)(4). THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 069270. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 104100. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 136870. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 180920. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 259865. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 286740. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 299410. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 325070. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 346380. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 361320. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 372540. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 389350. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 728330. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 823860. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 851100. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 852170. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 874620. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 926990. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - J6640277. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - J67048529. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - J6706527. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - J7820138. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - J7820140. G2: FOREIGN - EVENT OCCURRED IN SPAIN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.