MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-01-02 for GRAFTON DBM T43102 manufactured by Osteotech. Inc.
[63688591]
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.
Patient Sequence No: 1, Text Type: N, H10
[63688592]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246640-2017-00001 |
| MDR Report Key | 6217069 |
| Report Source | CONSUMER |
| Date Received | 2017-01-02 |
| Date of Report | 2016-12-21 |
| Date Mfgr Received | 2016-12-21 |
| Device Manufacturer Date | 2015-03-13 |
| Date Added to Maude | 2017-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GREG ANGLIN |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | OSTEOTECH. INC |
| Manufacturer Street | 201 INDUSTRIAL WAY WEST |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTON DBM |
| Generic Name | BONE GRAFTING MATERIAL, HUMAN SOURCE |
| Product Code | NUN |
| Date Received | 2017-01-02 |
| Model Number | NA |
| Catalog Number | T43102 |
| Lot Number | NA |
| Device Expiration Date | 2018-03-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOTECH. INC |
| Manufacturer Address | 201 INDUSTRIAL WAY WEST EATONTOWN NJ 07724 US 07724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-02 |