FDA Adverse Event
Other
Summary report: N
MAXIMUS OS IMPLANT
MDR report key: 654631
·
Received September 15, 2005
Report
- Report Number
- 1060818-2005-00001
- Event Type
- Other
- Date Received
- September 15, 2005
- Date of Event
- May 5, 2005
- Report Date
- August 17, 2005
- Manufacturer
- BIOHORIZONS IMPLANT SYSTEMS, INC.
- Product Code
- DZE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
THE CLINICIAN PREPPED A PATIENT FOR ENDOSSEOUS IMPLANTS, INCLUDING DRILLING OSTEOTOMIES, AND WAS NOT AWARE THAT DIFFERENT PLACEMENT INSTRUTMENTS, WHICH THE CUSTOMER HAD NOT RECEIVED, WERE NEEDED FOR THE IMPLANT MODEL BEING PLACED. THE CUSTOMER CLOSED THE SURGICAL SITES, RESCHEDULED THE PATIENT FOR THE PROCEDURE, AND SUBSEQUENTLY PLACED AND RESTORED THE IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXIMUS OS IMPLANT | ENDOSSEOUS DENTAL IMPLANT | DZE | BIOHORIZONS IMPLANT SYSTEMS, INC. | 3512OS4 | S1104001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |