MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-15 for SPF-PLUS 60/M manufactured by Ebi, Llc..
[49663612]
Patient Sequence No: 1, Text Type: N, H10
[49663613]
Patient had bone graft stimulator implanted approximately one year ago. The physician requested to remove the stimulator as it was not effectively progressing growth of the bone. This stimulator was not replaced at this time. No known injury occurred to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5797761 |
| MDR Report Key | 5797761 |
| Date Received | 2016-07-15 |
| Date of Report | 2016-07-01 |
| Date of Event | 2016-06-14 |
| Report Date | 2016-06-29 |
| Date Reported to FDA | 2016-06-29 |
| Date Reported to Mfgr | 2016-06-29 |
| Date Added to Maude | 2016-07-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF-PLUS 60/M |
| Generic Name | STIMULATOR, INVASIVE BONE GROWTH |
| Product Code | LOE |
| Date Received | 2016-07-15 |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC. |
| Manufacturer Address | 399 JEFFERSON RD PARSIPPANY, NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-15 |