inforMED
MalfunctionMBP

OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

Received May 8, 2019 · Event occurred Apr 16, 2019

Report 3005031160-2019-00024 · MDR key 8592175

Device

Generic name

Bone Void Filler

Model number

359100

Lot number

B180228-DBM

Product problems

  • Labelling, Instructions for Use or Training Problem
  • Device Markings/Labelling Problem
  • Inaccurate Information
  • Labelling, Instructions for Use or Training Problem
  • Device Markings/Labelling Problem
  • Inaccurate Information

Patient

60 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

A COMPLAINT WAS REPORTED ON (B)(6) 2019 INDICATING THAT DEVICES CONTAINING DBM PUTTY WERE LABELED WITH A VOLUME OF 10.0CC, HOWEVER, WHEN THE POUCHES WERE OPENED FOR USE, THE SYRINGES CONTAINED 5.0CC OF DBM PUTTY. THE COMPLAINANT REPORTED THAT THREE DEVICES DISPLAYING THE SAME DEFECT HAD BEEN IMPLANTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS WITH THIS EVENT. THE FOLLOWING MDR SUBMISSIONS ARE RELATED TO THIS EVENT: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025. THE COMPLAINANT RETURNED THREE ADDITIONAL DEVICES FROM THE SAME LOT NUMBER. UPON OPENING THE FOIL POUCH ON ONE DEVICE, IT WAS CONFIRMED THAT THE DBM PUTTY WAS AS DESCRIBED BY THE COMPLAINANT. THE DEVICE WAS LABELED AS CONTAINING 10.0CC OF DBM PUTTY, HOWEVER, ONLY CONTAINED 5.0CC OF DBM PUTTY.

Description of Event or Problem

A COMPLAINT WAS REPORTED ON (B)(6) 2019 INDICATING THAT DEVICES CONTAINING DBM PUTTY WERE LABELED WITH A VOLUME OF 10.0CC, HOWEVER, WHEN THE POUCHES WERE OPENED FOR USE, THE SYRINGES CONTAINED 5.0CC OF DBM PUTTY. THE COMPLAINANT REPORTED THAT THREE DEVICES DISPLAYING THE SAME DEFECT HAD BEEN IMPLANTED. THE FOLLOWING MDR SUBMISSIONS ARE RELATED TO THIS EVENT: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025.

Remedial action

  • Recall