MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-24 for CANCELLOUS CHIPS, 30 CC * 800150 manufactured by Musculoskeletal Transplant Foundation.
[335880]
Three examples of musculoskeletal transplant foundation cancellous bone chips. Aluminum bottle seals were not securely crimped onto bottles ie. Seals not complete. Reported to mtf via voice-mail. No response to date. These were not implanted in pt. One previous example has been returned to the supplier. Poor packaging for sterile material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031931 |
| MDR Report Key | 525687 |
| Date Received | 2004-04-24 |
| Date of Report | 2004-04-24 |
| Date Added to Maude | 2004-05-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CANCELLOUS CHIPS, 30 CC |
| Generic Name | HUMAN ALLOGRAFT TISSUE |
| Product Code | LMO |
| Date Received | 2004-04-24 |
| Model Number | * |
| Catalog Number | 800150 |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 2006-12-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 514823 |
| Manufacturer | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| Manufacturer Address | 1232 MID VALLEY DR. JESSUP PA 18434 US |
| Brand Name | CANCELLOUS CHIPS, 30 CC |
| Generic Name | ALLOGRAFT TISSUE |
| Product Code | LMO |
| Date Received | 2004-04-24 |
| Model Number | * |
| Catalog Number | 800150 |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 2006-12-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 514824 |
| Manufacturer | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| Manufacturer Address | 1232 MID VALLEY DR JESSUP PA 18434 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-04-24 |