MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-03-22 for DBX UNKNOWN manufactured by Musculoskeletal Transplant Foundation.
[40908874]
The serial number of the dbx is currently unknown. It was reported the patient experienced an infection after being implanted with a zero-p va implant with two screws and demineralized bone matrix (dbx) at level c4-c5 on (b)(6) 2015 for a c5 fracture/partial corpectomy, hardware migration, neck pain and dysphagia. The patient was treated with an unknown antibiotic and the infection cleared up a few weeks later. The implant has not been explanted. The patient visited the emergency room for falling down stairs on three separate occasions, (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
[43725141]
Due to the lack of confirmed donor and graft serial number information, a review of the suitability and processing batch records could not be performed. All available information was reviewed by the mtf's medical director who indicated the following, "alleged infection after implant of hardware and dbx (b)(4) 2015, but no cultures or other details. No serial numbers, thus impossible to investigate further. Patient apparently recovered well. " should mtf receive any additional information regarding this report, it shall be forwarded to the fda. No further investigation can be performed. This event is considered closed.
Patient Sequence No: 1, Text Type: N, H10
[43725142]
Ther serial number of the dbx is currently unknown. It was reported the patient experienced an infection after being implanted with a zero-p va implant with two screws and demineralized bone matrix (dbx) at level c4-c5 on (b)(6) 2015 for a c5 fracture/partial corpectomy, hardware migration, neck pain and dysphagia. The patient was treated with an unknown antibiotic and the infection cleared up a few weeks later. The implant has not been explanted. The patient visited the emergency room for falling down stairs on three separate occasions, (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249062-2016-00001 |
| MDR Report Key | 5517345 |
| Report Source | OTHER |
| Date Received | 2016-03-22 |
| Date of Report | 2016-04-25 |
| Date of Event | 2015-03-12 |
| Date Mfgr Received | 2016-02-22 |
| Date Added to Maude | 2016-03-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MARY AGOSTISI |
| Manufacturer Street | 125 MAY STREET |
| Manufacturer City | EDISON NJ 08837 |
| Manufacturer Country | US |
| Manufacturer Postal | 08837 |
| Manufacturer Phone | 7326613160 |
| Manufacturer G1 | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| Manufacturer Street | 125 MAY STREET |
| Manufacturer City | EDISON NJ 08837 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08837 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DBX |
| Generic Name | BONE VOID FILLER |
| Product Code | MBP |
| Date Received | 2016-03-22 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| Manufacturer Address | 125 MAY STREET EDISON NJ 08837 US 08837 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-22 |