MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-22 for UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[184416391]
The following products were used in the surgery. Some of the below products are not approved for sale in us. For such products, the similar products that are approved for sale in us are mentioned in the brackets: product id: g9010001540, lot: h5581935, qty. : (b)(4),(k): k153589, udi: (b)(4). Product id: 55740005525, lot: h5553305, qty. : (b)(4). (similar product id: 55840005525, 510(k): k113174, udi: (b)(4)). Product id: 55740005520, lot: h5489003, qty. : (b)(4). (similar product id: 55840005520, 510(k): k113174, udi: (b)(4)). Product id: 55740005520, lot: h5264293, qty. : (b)(4). (similar product id: 55840005520, 510(k): k113174, udi: (b)(4)). Product id: 8219500, lot: vs18c001, qty. : (b)(4), 510(k): k163181, udi: (b)(4). Product id: 8205300, lot: ct18b033, qty. : (b)(4), 510(k): k163181, udi: (b)(4). Product id: 8205300, lot: ct17f014, qty. : (b)(4), 510(k): k163181, udi: (b)(4). Product id: 7078396, lot: h5569567, qty. : (b)(4). (similar product id: 5540030, 510(k): k113174, udi: (b)(4)). Product id: 7078396, lot: h5590071, qty. : (b)(4). (similar product id: 5540030, 510(k): k113174, udi: (b)(4)). Product id: 7078396, lot: h5590104, qty. : (b)(4). (similar product id: 5540030, 510(k): k113174, udi: (b)(4)). Product id: 55740006535, lot: h5530456, qty. : (b)(4). (similar product id: 55840006535, 510(k): k113174, udi: (b)(4)). Product id: 55740006545, lot: h5571645, qty. : (b)(4). (similar product id: 55840006545, 510(k): k113174, udi: (b)(4)). Product id: 5531199, lot: 0686003w, qty. : (b)(4) (similar product id: 5541199, 510(k): k132471, udi: (b)(4)). Product id: 5531198, lot: 0684985w, qty. : (b)(4). (similar product id: 5541198, 510(k): k132471, udi: (b)(4)). Product id: g869h021, lot: 0579956w, qty. : (b)(4). (similar product id: 869-021, 510(k): k040962, udi: (b)(4)). Product id: 55740006545, lot: h5566395, qty. : (b)(4). (similar product id: 55840006545, 510(k): k113174, udi: (b)(4)). Product id: 55740006535, lot: h5530456, qty. : (b)(4). (similar product id: 55840006535, 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184416392]
It was reported that the patient presented with pseudoarthrosis after compression fracture at t12 and l1. She underwent thoracolumbar vertebral posterior fusion at t10-l4. Issues such as intra-operative massive bleeding was not found during the operation in which the reported products were implanted and the operation itself had been completed without any problems. Anterior fixation was scheduled to be performed on (b)(6) 2020. However, the patient? S health condition worsened on (b)(6) 2020; and on (b)(6) 2020, the patient died. The cause of death was not known. Postoperative necropsy was not performed according to the wishes of the patient's families, and it became impossible to determine the cause of death. Originally, the patient had thrombus in the lower limbs and had a poor heart function, and because the patient? S general condition was not good, the scheduled operation has been once postponed, and this surgery was performed. It was said the operation was performed after the patient and the patient? S families were told that the risk level was high. Doctor? S additional comments: the surgeon considered that it was not a problem related to the implants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00350 |
| MDR Report Key | 9863781 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-22 |
| Date of Report | 2020-03-22 |
| Date of Event | 2020-02-23 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-22 |
| 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 | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Product Code | KWP |
| Date Received | 2020-03-22 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Death | 2020-03-22 |