D
Patient 1
(B)(6), REPORTED THAT PATIENT HAD A SINUS AUGMENTATION PROCEDURE DUE TO INADEQUATE VERTICAL HEIGHT FOR FUTURE DENTAL IMPLANT PROCEDURE AND DEVELOPED AN INFECTION.
MAUDE MDR 2348984
- MDR report key
- 2348984
- Report number
- 1225520-2011-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-08-05
- Date received
- 2011-11-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- G. MURACA
- Address
- 40 GRISSOM RD SUITE 100 PLYMOUTH MA 02360 US
- Phone
- 508-508-5087
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HARVEST SMARTPREP2 CENTRIFUGE SYSTEM, APC60 | PLATELET CONCENTRATION SYSTEM | HARVEST TECHNOLOGIES CORPORATION | JQC | APC60 | APC60 | APC60-0101 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-11-16 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE PATIENT WAS PLACED ON PROPHYLACTIC ANTIBIOTICS THE DAY BEFORE SURGERY AND CONTINUED TO TAKE THEM DURING THE COURSE OF THE INFECTION. ANTIBIOTICS WERE CHANGED DURING THE COURSE OF THE INFECTION AND A DRAIN WAS PLACED. ANTIBIOTIC THERAPY: AMOXICILLIN DAY PRIOR TO SURGERY, (B)(6) 2011 AUGMENTIN/FLAGYL, (B)(6) 2011 EXTENDED FLAGYL COURSE, (B)(6) 2011 EXTENDED AUGMENTIN COURSE. THERE WAS NO EVIDENCE AND CONTINUES TO BE NO EVIDENCE OF INFECTION ASSOCIATED WITH A ROOT CANAL OR ANY ABSCESS. THE SINUS MEMBRANE WAS INTACT AND NOT COMPROMISED. PATIENT HAD UNREMARKABLE MEDICAL HISTORY. HOSPITALIZATION WAS NOT NECESSARY. THERE WAS NO PERMANENT INJURY OR DISABILITY. INFECTION HAS RESOLVED. PATIENT IS DOING WELL TODAY AND WILL BE GETTING AN IMPLANT IN THE FUTURE.