MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-16 for INFUSE BONE GRAFT 7510600 manufactured by Medtronic Sofamor Danek Usa, Inc.
[21846971]
It was reported that the patient presented with atrophic mandible. The patient underwent a surgical procedure including a bone graft to increase cadaver bone and height and width, in preparation for dental implants to restore back to mastication. Bone graft and rhbmp-2/acs were used. The products were placed through subperiosteal, tunneling. At an unknown time post-op, the surgeon noticed post-op suture line complications. The physician reported that the patient never healed at the site where the dental procedure was performed. A biopsy at the incision line opening of the dental area was performed. The patient was diagnosed with squamous-cell carcinoma on (b)(6) 2014. Treatment to date is radical neck resection, the resection of the mandible, removal of the lymph nodes and the tumor, reconstruct the mandible with a tibia graft, radiation and chemotherapy. The patient's quality of life will be greatly altered.
Patient Sequence No: 1, Text Type: D, B5
[22145843]
(b)(4). Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. Products from multiple manufacturers were implanted during the procedure. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
Patient Sequence No: 1, Text Type: N, H10
[23445598]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23445599]
On (b)(6) 2013, patient underwent dental surgery for atrophic mandible using rhbmp-2/acs and bone block. On (b)(6) 2013, the patient had a fistula tract on the anterior portion of her inferior lip below the inferior labial frenulum. She was put on an antibiotic. On (b)(6) 2013, the doctor debrided the fistula tract and removed one bone retention screw. The patient remained on antibiotic. On (b)(6) 2014, patient was having discomfort in lower left region of ridge. On (b)(6) 2014, doctor debrided the area on lower left region of ridge. Pt was doing better and healing was good after debridement. On (b)(6) 2014, patient was having discomfort on lower left region of ridge again. On (b)(6) 2014, doctor debrided the area again and removed some free floating bone block that was used with rhbmp-2/acs. On (b)(6) 2014, the healing was not within normal limits, and the patient was referred to another physician. The patient was diagnosed with breast cancer after she was last seen at the dental office (after (b)(6) 2014).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2014-04056 |
| MDR Report Key | 4177578 |
| Report Source | 05 |
| Date Received | 2014-10-16 |
| Date of Report | 2014-09-18 |
| Date Mfgr Received | 2014-11-03 |
| Device Manufacturer Date | 2013-08-02 |
| Date Added to Maude | 2014-10-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSE BONE GRAFT |
| Generic Name | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET |
| Product Code | NPZ |
| Date Received | 2014-10-16 |
| Model Number | NA |
| Catalog Number | 7510600 |
| Lot Number | M111202AAK |
| ID Number | NA |
| Device Expiration Date | 2015-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-16 |