MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-07 for MTF PUTTY * manufactured by Musculoskeletal Transplant Foundation.
[376096]
While orthopedic spine surgeon was applying the mtf putty to the operative area, the glass syringe got caught on the previously placed lumbar (screw heads) instrumentation. The glass syringe containing the putty broke and pieces of it (shards) shattered into the operative site. The surgeon then removed and washed the pieces. The size of the glass that was separated from the body of the syringe was approximately the size of a pencil eraser.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 565908 |
| MDR Report Key | 565908 |
| Date Received | 2005-01-07 |
| Date of Report | 2005-01-07 |
| Date of Event | 2004-12-07 |
| Report Date | 2005-01-07 |
| Date Reported to FDA | 2005-01-07 |
| Date Added to Maude | 2005-01-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTF PUTTY |
| Generic Name | MTF PUTTY |
| Product Code | LMO |
| Date Received | 2005-01-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 035383471182 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 555696 |
| Manufacturer | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| Manufacturer Address | 125 MAY STREET EDISON NJ 08837 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-07 |