FDA Adverse Event
Malfunction
Summary report: N
NORIAN CRS CEMENT
MDR report key: 2024018
·
Received March 14, 2011
Report
- Report Number
- 2939274-2011-00004
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Report Date
- February 16, 2011
- Manufacturer
- SYNTHES NORIAN
- Product Code
- GXP
- PMA / PMN Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
AN ARTICLE REVIEWING TWO CASES FROM (B)(6), DISCUSSES THE USE OF NORIAN CRS IN CONJUNCTION WITH TITANIUM IMPLANTS TO TREAT DEFORMITY OF THE MIDFACE AND ENOPHTHALMOS. A PATIENT UNDERWENT CORRECTIVE OSTEOTOMY AND REPLATING FOR ORBITAL FLOOR DEFECTS. ILIAC CREST BONE GRAFT, SYNPOR MESH AND 3CC OF NORIAN CRS WERE USED TO TREAT THE PATIENT. ARTICLE NOTED COMPLETE WOUND HEALING AND PATIENT REPORTED GOOD SATISFACTION WITH THE RESULTS. ADVERSE EVENT REPORTED AS MILD CHEMOSIS WHICH RESOLVED WITHIN 3-4 WEEKS POST OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NORIAN CRS CEMENT | NORIAN CRS CEMENT | GXP | SYNTHES NORIAN | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | MESH| PLATE |