FDA Adverse Event
Other
Summary report: N
ORTHOBLOCKS
MDR report key: 42923
·
Received October 18, 1996
Report
- Report Number
- 2023141-1996-00159
- Event Type
- Other
- Date Received
- October 18, 1996
- Report Date
- October 4, 1996
- Manufacturer
- CALCITEK
- Product Code
- MBE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
THIS REPORT REPRESENTS A LAWSUIT FILED BY SINGLE LAW FIRM AGAINST A MEDICAL PRACTICE, THE HOSP AND CO. THE PT'S ATTORNEY HAD ALLEGED PERMANENT PHYSICIAL IMPAIRMENT (DEFINED IN 21 CFR PART 803.S AS A SERIOUS INJURY) AND DISABILITY, AND PAIN, SUFFERING AND MENTAL ANGUISH IN A PT WHO WAS IMPLANTED WITH THE DEVICE DURING ANTERIOR CERVICAL DISECTOMY. USE OF THIS DEVICE IN ANTERIOR CERVICAL DISECTOMY PROCEDURE IS NOT RECOMMENDED BY THE MFR. THE CO HAS DENIED THE ALLEGATIONS AND DOES NOT BELIEVE THAT THE COMPLAINT REPRESENTS A REPORTABLE EVENT. HOWEVER, TO EN ON THE SIDE OF CAUTION, THIS REPORT IS BEING MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOBLOCKS Implant | HA BONE GRAFT BLOCKS FOR ORTHOGNATIC USE | MBE | CALCITEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |