MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-06 for INFUSE BONE GRAFT 7510200 manufactured by Medtronic Sofamor Danek Usa, Inc.
[126217814]
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. 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[126217815]
It was reported that the patient was pre-operatively diagnosed with l4-s2 pseudo arthrosis with broken spinal instrumentation, intractable back pain and underwent the following procedures: l4-l5 and l5-s1 anterior lumbar interbody fusion. Placement of peek cage screw construct l4-l5 and l5-s1, allograft bone matrix, bone morphogenic protein. Neuromonitoring. Removal of instrumentation l4 through s1, revision spinal instrumentation l4 to the ilium, revision posterolateral fusion, l4 to ilium, local morcellized autograft, allograft bone matrix, bone morphogenic protein, neuromonitoring, intraoperative o-arm ct scan with computer navigation, connection of fusion to prior t10-l4 instrumentation. As per op-notes,? The set screws from l4 down to the ilium were removed. The broken rod was removed and then the remaining rods were cut up above the l4 level. The loose screws at l4 through s1 were removed. O-arm registration was placed in the iliac crest. O-arm was brought in for intraoperative ct scan. Computer registration materials verified. Under computer guidance, new screws were placed from l4 down to the ilium. O arm brought back in to verify good placement of instrumentation, rods were then cut and contoured to appropriate shape and length, placed over the new screws from l4 to the ilium bilaterally and connected to the previously placed rods from t10 down to the l3, connected with side-to-side connectors. Set screws were placed and final tightened. A high-speed decorticating burr was used to decorticate the remaining bony surfaces l3 down to the ilium. Irrigation performed. Homeostasis achieved. Remaining local morcellized autograft, allograft bone matrix, bone morphogenic protein were packed over the decorticated surfaces at l 3 down to the ilium. Subfascial drain placed.? The operative findings were: pseudo arthrosis, l4-l5 and l5-s1, with broken spinal instrumentation. No sustained neuromonitoring alerts. On (b)(6) 2017: the patient was discharged from the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-01450 |
| MDR Report Key | 8040718 |
| Report Source | CONSUMER |
| Date Received | 2018-11-06 |
| Date of Report | 2018-12-20 |
| Date Mfgr Received | 2018-12-05 |
| Device Manufacturer Date | 2017-11-15 |
| Date Added to Maude | 2018-11-06 |
| 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 | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| 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 | NEK |
| Date Received | 2018-11-06 |
| Model Number | NA |
| Catalog Number | 7510200 |
| Lot Number | M111701AAZ |
| Device Expiration Date | 2019-02-28 |
| 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. Other | 2018-11-06 |