N
Patient 1
NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
MAUDE MDR 6217069
- MDR report key
- 6217069
- Report number
- 2246640-2017-00001
- Event key
- 0
- Event type
- 3
- Date received
- 2017-01-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 305
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- GREG ANGLIN
- Address
- 1800 PYRAMID PLACE MEMPHIS TN 38132 US
- Phone
- 901-901-9013
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GRAFTON DBM | BONE GRAFTING MATERIAL, HUMAN SOURCE | OSTEOTECH. INC | NUN | NA | T43102 | NA | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-02 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2015, PATIENT UNDERWENT A SURGERY WHERE TITANIUM PLATE AND SCREWS WERE IMPLANTED AT LEVELS C4-5 AND C5-6. REPORTEDLY, POST-OP, PATIENT HAD SWELLING ON HIS NECK, RHEUMATOID ARTHRITIS AND AUTO-IMMUNE DISEASE. REPORTEDLY, ?PATIENT CANNOT WORK ANYMORE AND HIS SKIN NEAR NECK HAS TURNED RED.? PATIENT ALSO HAS A TUMOR. ALLERGY TEST REVEALED THAT THE PATIENT IS ALLERGIC TO NICKEL AND CHROMIUM. THE DOCTORS DO NOT KNOW WHAT THE SYMPTOMS ARE RELATED TO AND NOW ARE LOOKING AT THE DEVICES TO SEE IF HE MIGHT BE ALLERGIC TO THE DEVICES.