MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-02-28 for PRO OSTEON 500 BONE GRAFT SUBSTITUTE UNK manufactured by Interpore Cross Intl..
[19902448]
Patient had a lumber laminectomy using pro osteon 500 without any instrumentation. The surgeon performed nerve decompression at two levels and fusion at one level. Surgeon's files indicate that the patient did not follow up with the surgeon after surgery. According to the patient, the patient had to have two additional surgeries by a different surgeon due to continued pain at the original surgical site. These surgeries took place in 2000 and 2001. During the 2001 surgery, the surgeon noticed that the pro osteon 500 was "like putty or oatmeal... [and] was also suprised that there was no instrumentation in place for low back support" [quote is from patient, not the surgeon]. The patient has stated, "the area had to be cleaned out and then a new typical standard hip graft fusion with screws and rods was performed. " please not that the above information has not yet been confirmed with the surgeon. The patient has stated that they are still in pain and require five to six different pain medications daily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029012-2003-00004 |
| MDR Report Key | 445655 |
| Report Source | 00 |
| Date Received | 2003-02-28 |
| Date of Report | 2003-02-28 |
| Date of Event | 2001-09-01 |
| Date Mfgr Received | 2003-01-31 |
| Date Added to Maude | 2003-03-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CAROL BERARD |
| Manufacturer Street | 181 TECHNOLOGY DRIUE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494533200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO OSTEON 500 BONE GRAFT SUBSTITUTE |
| Generic Name | BONE GRAFT SUBSTITUTE |
| Product Code | LMN |
| Date Received | 2003-02-28 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 434631 |
| Manufacturer | INTERPORE CROSS INTL. |
| Manufacturer Address | 181 TECHNOLOGY DR. IRVINE CA 92618 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2003-02-28 |