MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-08-25 for SPF-PLUS IMPLANTABLE STIMULATOR N/A 10-1398M manufactured by Biomet Spine - Broomfield.
[52969986]
The physician's manual states "the generator may optionally be removed at the end of its useful life (approximately 24-weeks). " the full prescribing information states "indications:the spf plus-mini implantable fusion stimulator is indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels. The spf-xl iib implantable spinal fusion stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 3 or more levels. Usage:the spf has only been studied as an adjunct for lumbar spinal surgery. " review of device history records show the lot released with no recorded anomaly or deviation. Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[52969987]
Received the facility medwatch report which states "the patient had a 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 | 3004485144-2016-00196 |
| MDR Report Key | 5903427 |
| Report Source | OTHER |
| Date Received | 2016-08-25 |
| Date of Report | 2016-07-26 |
| Date of Event | 2016-06-14 |
| Date Mfgr Received | 2016-07-26 |
| Device Manufacturer Date | 2014-11-20 |
| Date Added to Maude | 2016-08-25 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer G1 | BIOMET SPINE - BROOMFIELD |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF-PLUS IMPLANTABLE STIMULATOR |
| Generic Name | SPF |
| Product Code | LOE |
| Date Received | 2016-08-25 |
| Model Number | N/A |
| Catalog Number | 10-1398M |
| Lot Number | 407907 |
| ID Number | N/A |
| Device Expiration Date | 2016-06-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPINE - BROOMFIELD |
| Manufacturer Address | 310 INTERLOCKEN PARKWAY SUITE 120 BROOMFIELD CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2016-08-25 |