inforMED
InjuryDZE

BRÅNEMARKSYST MKIII GROOVY RP3.75X11.5MM

Received Jun 22, 2019 · Event occurred Apr 8, 2019

Report 2027971-2019-00016 · MDR key 8725510

Device

Generic name

Endosseous Dental Implant

Catalog number

32121

Lot number

674471

Product problems

  • Improper or Incorrect Procedure or Method
  • Improper or Incorrect Procedure or Method

Patient

73 YR

  • Unspecified Infection
  • Unspecified Infection

Narrative

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

ISSUE DESCRIPTION: AN ORIGINAL BRANEMARK WAS PLACED IN 1992 WITH A LOWER HYBRID BRIDGE IN FIVE IMPLANTS. IMPLANT ON POSITION #28 HAD 50% BONELOSS AND WAS REMOVED, REPLACED BY A BRÅNEMARKSYST MKIII GROOVY RP3.75X11.5MM ON (B)(6) 2019. THE CUSTOMER REPORTED TO NOBEL BIOCARE THAT ON (B)(6) 2019 THE PATIENT EXPERIENCED OSTEOMYELITIS OF THE MANDIBLE. THE FIXTURE WAS REMOVED AND THE PATIENT RECEIVED SIX WEEKS OF ANTIBIOTICS AND HAD A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACED. THE PATIENT WAS FULLY RECOVERED WHEN CHECKED POST OPERATION ON (B)(6) 2019.

Additional Manufacturer Narrative

INTERNAL REFERENCE NUMBER: (B)(4). THIS COMPLAINT WAS PREVIOUSLY INCORRECTLY REPORTED UNDER 2027971-2019-00016 AS A MANUFACTURER REPORT. THE MEDICAL DEVICE WAS HOWEVER NOT MANUFACTURED BUT IMPORTED BY NOBEL BIOCARE UNDER SITE REGISTRATION NUMBER (B)(4). THE MEDICAL DEVICE WAS ACTUALLY MANUFACTURED UNDER SITE REGISTRATION NUMBER (B)(4). THIS REPORT (2027971-2019-00016) IS NOW CHANGED TO AN UF/IMPORTER REPORT IN THIS FOLLOW UP REPORT.

Description of Event or Problem

ISSUE DESCRIPTION AN ORIGINAL BRANEMARK WAS PLACED IN 1992 WITH A LOWER HYBRID BRIDGE IN FIVE IMPLANTS. IMPLANT ON POSITION #28 HAD 50% BONE LOSS AND WAS REMOVED, REPLACED BY A BRÅNEMARKSYST MKIII GROOVY RP3.75X11.5MM ON (B)(6) 2019. THE CUSTOMER REPORTED TO NOBEL BIOCARE THAT ON (B)(6) 2019 THE PATIENT EXPERIENCED OSTEOMYELITIS OF THE MANDIBLE. THE FIXTURE WAS REMOVED AND THE PATIENT RECEIVED SIX WEEKS OF ANTIBIOTICS AND HAD A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACED. THE PATIENT WAS FULLY RECOVERED WHEN CHECKED POST OPERATION ON (B)(6) 2019. THE RETURNED PRODUCT WAS RECEIVED OPENED AND USED. VISUAL INSPECTION AND MEASUREMENT OF THE RETURNED PRODUCT SHOWS THAT THE PRODUCT INFORMATION PROVIDED BY THE CUSTOMER IS CORRECT. THE INJURY AS DESCRIBED MAY HAVE BEEN CAUSED BY FAILURE TO FOLLOW PROCEDURES. THIS BATCH, 674471, WAS EXPIRED ON 14-JANUARY-2012, AS INDICATED ON THE LABEL..