FDA Adverse Event
Malfunction
Summary report: N
NUOSS CANCELLOUS
MDR report key: 7834348
·
Received August 30, 2018
Report
- Report Number
- 2249852-2018-00009
- Event Type
- Malfunction
- Date Received
- August 30, 2018
- Report Date
- August 28, 2018
- Manufacturer
- COLLAGEN MATRIX, INC.
- Product Code
- NPM
- UDI-DI
- 00614950007431
- PMA / PMN Number
- K043034
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL TESTING PERFORMED ON THE RESERVE PRODUCT SAMPLES CONFIRMS THAT THE PRODUCT MEETS ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
THE CLINICIAN REPORTED THAT THE PATIENT UNDERWENT A BONE GRAFT PROCEDURE AND OBSERVED NO INTEGRATION. THE MATERIAL APPEARED DISCOLORED AND DARKER IN SHADE. NO INFECTION WAS OBSERVED. THE CLINICIAN PERFORMED A FOLLOW-UP PROCEDURE TO REMOVE THE ORIGINAL BONE GRAFT AND RE-GRAFTED THE SITE USING ANOTHER PRODUCT. THERE WAS A DELAY IN PLACEMENT OF IMPLANT 4 TO 6 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673025 | NUOSS CANCELLOUS | BONE GRAFTING MATERIAL | NPM | COLLAGEN MATRIX, INC. | 509 9002 | BM2CU15P1 | 00614950007431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |