MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-03-01 for HEALOS DENTAL, BONE GRAFT REPLACEMENT 2.5CC 1 STRIP/POUCH 6325 manufactured by Depuy Spine, Inc..
[1460367]
It was reported that a dmd placed healos dental in a (b) (6) male for a bridge. He did not use any membrane, but packed the socket with healos. The patient returned 9 months later. The doctor found the socket filled with soft mushy healos. There was no change to the consistency of the healos. He removed the healos and used freeze dried bone. The patient has no medical issues or altered healing. As an adverse outcome was reported an mdr is filed to document this event.
Patient Sequence No: 1, Text Type: D, B5
[8516863]
No conclusions can made at this time. Bone growth would be expected 9 months after placement. An event of this nature could be due to one of two things (or a combination of the two). First, the product may not have been sufficiently soaked with blood prior at time of placement. Second, it may have been over packed. Both could potentially adversely affect the expected replacement with new bone.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2010-00043 |
| MDR Report Key | 1620014 |
| Report Source | 05,08 |
| Date Received | 2010-03-01 |
| Date of Event | 2010-02-11 |
| Date Mfgr Received | 2010-02-11 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2010-03-05 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEALOS DENTAL, BONE GRAFT REPLACEMENT 2.5CC 1 STRIP/POUCH |
| Generic Name | BONE GRAFT REPLACEMENT / NPM |
| Product Code | NPM |
| Date Received | 2010-03-01 |
| Model Number | NA |
| Catalog Number | 6325 |
| Lot Number | 09B008 |
| ID Number | NA |
| Device Expiration Date | 2010-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-01 |