MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-12 for INTERGRO DBM * DBM010 manufactured by Interpore Cross International.
[338477]
Add'l info rec'd from mfr 9/03/04: a thorough review of the donor's charts, including processing documentation and cultures, by the supplier showed that this product was produced and labeled according to existing procedures and met release specifications. Final packaging cultures and destructives conducted by the supplier were also found to be negative. Futhermore, an investigation into this event was performed by the center for disease control and prevention (cdc). Based on the info the cdc obtained, they stated that the evidence suggests that this was likely not an allograft associated event. Attached is the final report from the cdc.
Patient Sequence No: 1, Text Type: D, B5
[18914226]
Pt had a posterior spine fusion with instrumentation and iliac crest bone graft for idiopathic scoliosis. Demineralized bone matrix allograft was placed in the iliac crest donor bed prior to closure. No drain was placed. On post-op day 17 the incision started draining pus. No fever. Pt had a deep infection down to the iliac crest. Pt has required two irrigation and debridements, and will need four weeks of iv antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032094 |
| MDR Report Key | 528060 |
| Date Received | 2004-05-13 |
| Date of Report | 2004-05-12 |
| Date of Event | 2004-05-07 |
| Date Added to Maude | 2004-06-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERGRO DBM |
| Generic Name | INTERPORE CROSS |
| Product Code | LMO |
| Date Received | 2004-05-12 |
| Model Number | * |
| Catalog Number | DBM010 |
| Lot Number | 020345 018 |
| ID Number | * |
| Device Expiration Date | 2004-06-30 |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 517248 |
| Manufacturer | INTERPORE CROSS INTERNATIONAL |
| Manufacturer Address | 181 TECHNOLOGY DRIVE IRVINE CA 926182402 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-05-13 |