FDA Adverse Event
Malfunction
Summary report: N
BONESOURCE HAC
MDR report key: 194151
·
Received October 26, 1998
Report
- Report Number
- 2183449-1998-00004
- Event Type
- Malfunction
- Date Received
- October 26, 1998
- Date of Event
- August 5, 1998
- Report Date
- October 22, 1998
- Manufacturer
- OSTEOGENICS INC.
- Product Code
- GXP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A PT PRESENTED WITH A LARGE DEFECT OF THE TEMPORAL LOBE OF THE CRANIUM, THE PHYSICIAN IMPLANTED 100 GRAMS OF BONESOURCE MATERIAL INTO THE DEFECT (NOTE - PRODUCT LABELING STATES THAT MAXIUMUM OF 85 GRAMS PER DEFECT SHOULD BE USED). ADD'L, THE DEVICE WAS IMPLANTED OVER PULSATING DURA. CRACKING WAS OBSERVED IN THE INITIAL SETTING PHASE. THE PHYSICIAN REMOVED THE BONESOURCE AND COMPLETED THE PROCEDURE WITH AN ALTERNATIVE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BONESOURCE HAC Implant | HYDROXYAPATITE CEMENT | GXP | OSTEOGENICS INC. | UNK | S412B8 AND S425B8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |