MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-16 for SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR N/A 10-1335M manufactured by Biomet Spine - Broomfield.
[25992662]
Without a product return, no product evaluation is able to be conducted. The lot number is 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.
Patient Sequence No: 1, Text Type: N, H10
[25992663]
The patient reported undergoing a procedure in (b)(6) 2008 to repair a ruptured disk and an implantable bone stimulator was utilized following the procedure. Subsequently, patient reports allegations of pain and a lump in the location of the implanted bone stimulator. Patient further alleges the stimulator was removed in (b)(6) 2010, but alleges that a portion of the stimulator remains implanted based on alleged mri evidence. Patient further alleges that screws, rods and plates from an unknown manufacturer remain implanted. Patient alleges damage to organs and tissue for which patient is allegedly being treated by a pain management physician. This report is based on patient's allegations the above allegations have not been verified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004485144-2015-00052 |
| MDR Report Key | 5081829 |
| Date Received | 2015-09-16 |
| Date of Report | 2015-08-18 |
| Date Mfgr Received | 2015-08-18 |
| Date Added to Maude | 2015-09-16 |
| 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 | PATIENT |
| 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 | SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR |
| Generic Name | IMPLANTABLE SPINAL FUSION STIMULATOR |
| Product Code | LOE |
| Date Received | 2015-09-16 |
| Model Number | N/A |
| Catalog Number | 10-1335M |
| 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 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2015-09-16 |