OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
Received Nov 19, 2020 · Event occurred Oct 21, 2020
Report 3005031160-2020-00033 · MDR key 10872245
Device
Product problems
- Improper or Incorrect Procedure or Method
- Expiration Date Error
- Improper or Incorrect Procedure or Method
- Expiration Date Error
Patient
46 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COMPANY ROUTINELY ISSUES COMMUNICATIONS REGARDING EXPIRING PRODUCT TO SALES PERSONNEL. THIS COMMUNICATION INCLUDES A LIST OF SERIAL NUMBERS AND LOCATIONS FOR EXPIRING PRODUCT. THIS LIST IS INTENDED TO BE USED BY THE SALES REPRESENTATIVES TO ENSURE THAT EXPIRING PRODUCT IS APPROPRIATELY DISCARDED. AN EXPIRING TISSUE FIELD NOTIFICATION WAS EMAILED TO SALES PERSONNEL ON 01/03/2020, WHICH INCLUDED THE EXPIRATION DATE (04/04/2020), AND LOCATION OF THE COMPLAINT GRAFT. THIS GRAFT HAD BEEN AT THE SURGICAL FACILITY SINCE 06/14/2018. THE COMPLAINANT RECEIVED THE EXPIRING TISSUE FIELD NOTIFICATION FROM THE COMPANY ON 1/03/2020. THE GRAFT WAS NOT APPROPRIATELY DISCARDED OR RETURNED TO THE COMPANY AS INSTRUCTED.
Description of Event or Problem
THE COMPANY RECEIVED NOTIFICATION ON 10/21/2020 FROM A SALES DISTRIBUTOR THAT A COMBINATION PRODUCT GRAFT HAD BEEN IMPLANTED BEYOND THE EXPIRATION DATE IDENTIFIED ON THE PRODUCT PACKAGE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS REPORT OF AN IMPLANTED EXPIRED DEVICE.