MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for EBI SPF-XL IIB BONE GROWTH STIMULATOR 10-1335M manufactured by Zimmer Biomet Spine Inc..
[144415110]
I had an ebi spf-xl iib bone growth stimulator, the model is unk, sn is (b)(4). I have suffered swelling, infection, nerve pain, chronic pain and the inability to live a normal life since. No physician would take it out. In january of this year a pain mgmt dr finally took it out and the infections and horrible pain cleared, and the ability to live is now coming back. A medical device should not cause people harm the way that stimulator did to me. I lost 12 years of my life for something implanted that died 6 months after it was installed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086389 |
| MDR Report Key | 8582592 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-01 |
| Date of Event | 2006-11-14 |
| Date Added to Maude | 2019-05-06 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | EBI SPF-XL IIB BONE GROWTH STIMULATOR |
| Generic Name | STIMULATOR, INVASIVE BONE GROWTH |
| Product Code | LOE |
| Date Received | 2019-05-03 |
| Model Number | 10-1335M |
| Catalog Number | 10-1335M |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET SPINE INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-05-03 |