MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-02-28 for DBX PUTTY, 10CC 038100 manufactured by Musculoskeletal Transplant Foundation.
[68550494]
Implanted.
Patient Sequence No: 1, Text Type: N, H10
[68550495]
On 1/27/2017, mtf was notified that a patient of dr. (b)(6) who was implanted with dbx three weeks ago tested (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[72692538]
All assigned investigation tasks have been completed. There were no patient safety concerns or trends identified; no core gtp violations were noted. The donor and processing batch records for donor (b)(6) were re-reviewed. The donor was appropriately screened and tested in accordance with mtf's donor release criteria. The subject allograft met specification and was appropriately released for distribution and transplantation. The complaint unit was not returned to mtf for evaluation as the graft was implanted. There have been no additional complaints or adverse events received for donor (b)(6). A total of (b)(4) dbx putty units were produced from this donor, all of which have been distributed. There are 25 tissue trace records on file; there is a record on file is for the complaint unit. Environmental data showed that the locations were in control. As per mtf's medical director (dr. (b)(6)), "report of pos (b)(6) test in patient who received dbx implant weeks before. Attempts to get further info on this patient about how long they were known to be pos or what signs and symptoms were present or what risk behaviors were known were unsuccessful. In addition, (b)(6) is widely prevalent to otherwise well patients undergoing surgery. And dbx is highly processed by techniques validated to inactivate viruses including (b)(6). Thus there is no evidence to link the graft to the patient's test result. " the investigation is considered closed.
Patient Sequence No: 1, Text Type: N, H10
[72692539]
On 1/27/2017, mtf was notified that a patient of dr. (b)(6) who was implanted with dbx three weeks ago tested (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249062-2017-00001 |
| MDR Report Key | 6365389 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-02-28 |
| Date of Report | 2017-01-27 |
| Date of Event | 2016-06-21 |
| Date Mfgr Received | 2017-01-27 |
| Device Manufacturer Date | 2016-03-02 |
| Date Added to Maude | 2017-02-28 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MARY AGOSTISI |
| Manufacturer Street | 125 MAY STREET |
| Manufacturer City | EDISON NJ 08837 |
| Manufacturer Country | US |
| Manufacturer Postal | 08837 |
| Manufacturer Phone | 7326613160 |
| Manufacturer G1 | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| Manufacturer Street | 125 MAY STREET |
| Manufacturer City | EDISON NJ 08837 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08837 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DBX PUTTY, 10CC |
| Generic Name | FILLER, BONE VOID |
| Product Code | MBP |
| Date Received | 2017-02-28 |
| Model Number | 038100 |
| Catalog Number | 038100 |
| Device Expiration Date | 2018-01-21 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| Manufacturer Address | 125 MAY STREET EDISON NJ 08837 US 08837 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-28 |