MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-23 for EBI SPF? IMPLANTABLE SPINAL FUSION STIMULATOR N/A UNKNOWN manufactured by Biomet Spine - Broomfield.
[34920312]
Without a product return, no product evaluation is able to be conducted. The part number and lot number are unknown; therefore the device history records are unable to be reviewed. 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. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[34920313]
The mri technician reported a patient with a possible broken lead. The patient's neurosurgeon, who was treating the patient for headaches, ordered an mri. The mri technician identified a possible broken lead, therefore the mri could not be completed. Upon follow up with the patient she stated that she was implanted with the bone stimulator in 2010 or 2011 at l5-l1 at the fusion. In addition, she reported she was unaware of any issues until the mri appointment. The physician manual for this product states " "the generator may optionally be removed at the end of its useful life (approximately 24-weeks). " it is unknown when the lead broke as it has been implanted with no known issues since 2010 or 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004485144-2015-00116 |
| MDR Report Key | 5323036 |
| Date Received | 2015-12-23 |
| Date of Report | 2015-11-23 |
| Date Mfgr Received | 2015-11-23 |
| Date Added to Maude | 2015-12-23 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 Phone | 3034437500 |
| 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 | 0 |
| Brand Name | EBI SPF? IMPLANTABLE SPINAL FUSION STIMULATOR |
| Generic Name | BONE STIMULATOR |
| Product Code | LOE |
| Date Received | 2015-12-23 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| 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 | 2015-12-23 |