MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for DBX 227005 manufactured by Musculoskeletal Transplant Foundation, Inc..
[177634530]
Total hip arthroplasty: surgeon requested 4 of mft biologics aft straight tube (ref: (b)(4)) be opened to the field. With two of them, the surgeon could not get the product out of the tube. He asked for more and we had no more of the straight tubes and had to open a diverted tube (ref: (b)(4)). The diverted one did not work either. I took the diverted tube and two straight tubes off the field and made sure they were wasted in the patient chart. I put the diverted tube back in its package but was not able to know what packages correlated with the two faulty straight tubes. This report includes 1 aft diverted tube (3/4 filled) and its details and 2 aft straight tube (1/2 filled) with only limited details on 2nd package (tube was saved but box not saved).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9665340 |
| MDR Report Key | 9665340 |
| Date Received | 2020-02-04 |
| Date of Report | 2019-12-02 |
| Date of Event | 2019-11-25 |
| Report Date | 2019-12-03 |
| Date Reported to FDA | 2019-12-03 |
| Date Reported to Mfgr | 2020-02-04 |
| Date Added to Maude | 2020-02-04 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DBX |
| Generic Name | FILLER, BONE VOID, CALCIUM COMPOUND |
| Product Code | MQV |
| Date Received | 2020-02-04 |
| Catalog Number | 227005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
| Manufacturer Address | 125 MAY STREET EDISON NJ 08837 US 08837 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |