MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study,user facility report with the FDA on 2020-01-22 for SEE H10 manufactured by Medtronic Sofamor Danek Usa, Inc..
[178331400]
The following products were used in the surgery: product id: p1603m, lot#: mx99382aap, qty. : 1. Product id: 55840007560, lot#: h5568769, qty. : 2, 510(k): k113174, udi: (b)(4). Product id: 55840007555, lot#: h5557395, qty. : 1, 510(k): k113174, udi: (b)(4). Product id: 5540130, lot#: h5556147, qty. : 4, 510(k): k113174, udi: (b)(4). Product id: 5540130, lot#: h5436979, qty. : 4, 510(k): k113174, udi: (b)(4). Product id: 1553201080, lot#: unk, qty. : 1, 510(k): k113174, udi: (b)(4). Product id: 7510200, lot#: m111814aah, qty. : 1, pma: p000058, udi: (b)(4). Product id: 2990726, lot#: h5079379, qty. : 1, 510(k): k073291, udi: (b)(4). Product id: 2990726, lot#: h5519434, qty. : 1, 510(k): k073291, udi: (b)(4). Product id: 7800320, lot#: cccn19h7, qty. : 2, 510(k): k082166, udi: (b)(4). Product id: 1553201090, lot#: 0576966w, qty. : 1, 510(k): k113174, udi: (b)(4). Product id: 55840007550, lot#: h5526815, qty. : 2, 510(k): k113174, udi: (b)(4). Product id: 55840007560, lot#: h5554204, qty. : 3, 510(k): k113174, udi: (b)(4). Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose. 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
[178331401]
It was reported as per clinical study that the patient presented with stenosis with documented pre-operative instability at 3 levels. On (b)(6) 2019, the patient underwent fusion at 3 levels. Rods, screws, 4. 2 mg rhbmp-2/acs, grafts were implanted in the patient during this surgery. With an onset date of (b)(6) 2019, right sided l4-l5 radiculitis was reported. Hence, on (b)(6) 2019, decompression was performed at levels l2-l3, l3-l4, l4-l5 and l5-s1. There was stenosis at l2-l3 and hematoma that was compressing the l3-s1 thecal sac in the region of prior decompression. All of the thecal sac was fully decompressed with no remaining hematoma. Drug therapy was also performed as a part of intervention for this adverse event. The investigator noted the adverse event as non-serious. Site related assessment noted that the adverse event was unlikely related to interbody fusion, grafting material, posterior fixation; probably related to surgical procedure; and related to surgical construct and/or study procedure. However, according to sponsor assessment, the adverse event was possibly related to rhbmp-2/acs, grafting kit; and causally related to the surgical procedure. X-ray was performed on (b)(6) 2020, which showed normal results. The outcome of this adverse event is pending.
Patient Sequence No: 1, Text Type: D, B5
[188122259]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188122260]
The patient presented for an office visit on (b)(6) 2020. The outcome of the adverse event is now resolved with an outcome date of (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00096 |
| MDR Report Key | 9615738 |
| Report Source | STUDY,USER FACILITY |
| Date Received | 2020-01-22 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-01-22 |
| 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 | 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 |
| Generic Name | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET |
| Product Code | NEK |
| Date Received | 2020-01-22 |
| Model Number | NA |
| Catalog Number | SEE H10 |
| Lot Number | SEE H10 |
| 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 | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-22 |