MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-07-18 for SPF-PLUS 2/DM 10-1389M manufactured by Ebi, Llc.
[2127284]
Medwatch (b)(4) was received on june 22, 2011. The following information was obtained from the report: "bone growth stimulator installed in... Lower back. "... "result was no new bone growth, chronic back pain and permanent disability. "... "unit was removed... Determined the bone growth stimulator was defective, did not grow bone and caused severe back pain. " the allegations of the complaint are unverified. Spoke with patient for confirmation of the associated product. Patient indicated the serial number of the device was (b)(4). Also provided the name of surgeon and hospital. Confirmed that the implant date was (b)(6) 2006 and explant date was (b)(6) 2008. However, patient called back on june 27th to indicate correct implant date was (b)(6) 2004, and explant date was (b)(6) 2006. These dates could not be reconfirmed.
Patient Sequence No: 1, Text Type: D, B5
[9204718]
Per the manufacturing records, the item referenced (part number 10-1389m, serial number (b)(4)) was manufactured on august 29, 2005. This item was shipped to the healthcare facility on december 27, 2005. Additionally, per the physician manual, the operating period of the device is 26 weeks.
Patient Sequence No: 1, Text Type: N, H10
[18453771]
The initial report was submitted on (b)(4) 2011. (b)(4). The mfr report number was incorrectly identified as 2242816-2010-00080; 2242816-2011-00084 corresponds to the response for medwatch (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242816-2011-00084 |
| MDR Report Key | 2166502 |
| Report Source | 00 |
| Date Received | 2011-07-18 |
| Date of Report | 2011-06-22 |
| Date Mfgr Received | 2011-06-22 |
| Device Manufacturer Date | 2005-08-29 |
| Date Added to Maude | 2011-07-26 |
| 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 | ART KAUFMAN |
| Manufacturer Street | 100 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF-PLUS 2/DM |
| Generic Name | STIMULATOR, INVASIVE BONE GROWTH |
| Product Code | LOE |
| Date Received | 2011-07-18 |
| Catalog Number | 10-1389M |
| Lot Number | 405759 |
| Device Expiration Date | 2005-07-05 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC |
| Manufacturer Address | 100 INTERPACE PARKWAY PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-18 |