MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-08-29 for BIOVENTUS EXOGEN 4000+ SYSTEM 71034600 manufactured by Bioventus,llc.
[21106269]
Adverse event: numbness. While using the device off label to treat vertebrate l3 and l5 of the spine, the patient experienced numbness in her left leg.
Patient Sequence No: 1, Text Type: D, B5
[21170578]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010203571-2013-00003 |
| MDR Report Key | 3423214 |
| Report Source | 00 |
| Date Received | 2013-08-29 |
| Date of Report | 2013-08-21 |
| Date of Event | 2013-07-23 |
| Date Mfgr Received | 2013-07-25 |
| Date Added to Maude | 2013-10-23 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KANICHY ROYSTON |
| Manufacturer Street | 1900 CHARLES BRYAN RD SUITE 275 |
| Manufacturer City | CORDOVA TN 38016 |
| Manufacturer Country | US |
| Manufacturer Postal | 38016 |
| Manufacturer Phone | 9013412930 |
| Manufacturer G1 | BIOVENTUS |
| Manufacturer Street | 1900 CHARLES BRYAN RD SUITE 270 |
| Manufacturer City | CORDOVA TN 38016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOVENTUS EXOGEN 4000+ SYSTEM |
| Generic Name | EXOGEN 4000+ SYSTEM |
| Product Code | LPQ |
| Date Received | 2013-08-29 |
| Model Number | 71034600 |
| Catalog Number | 71034600 |
| Lot Number | 13EM0515 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOVENTUS,LLC |
| Manufacturer Address | CORDOVA TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-29 |