MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-14 for SPF SPINAL FUSION STIMULATOR N/A manufactured by Ebi, Llc..
[4184789]
Patient reports having an spf unit implanted on an unknown date. Subsequently, patient had an mri procedure on an unknown date and reports pain and discomfort in area where the spf unit was implanted. Patient reports that spf unit was explanted on an unknown date. Patient further reports pain and discomfort in the implant area after the revision.
Patient Sequence No: 1, Text Type: D, B5
[11654459]
No product was returned to manufacturer. Current information is insufficient to permit a conclusion as to the cause of the event. (b)(4). Mri statement is included with patient card and states the following: for mri centers: the biomet spf spinal fusion stimulator has received fda approval for the claim of mri safe for the spf-2t and spf-xl iib models when used in mr environments up to 1. 5 tesla. To access complete full prescribing and mri information, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002242816-2014-00014 |
| MDR Report Key | 3629042 |
| Report Source | 04 |
| Date Received | 2014-02-14 |
| Date of Report | 2014-01-16 |
| Date Mfgr Received | 2014-01-16 |
| Date Added to Maude | 2014-02-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DAVID TALISH |
| Manufacturer Street | 399 JEFFERSON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF SPINAL FUSION STIMULATOR |
| Generic Name | STIMULATOR |
| Product Code | LOE |
| Date Received | 2014-02-14 |
| Model Number | N/A |
| 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 | EBI, LLC. |
| Manufacturer Address | 399 JEFFERSON ROAD PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-14 |