MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for ENDOSKELETON? TAS NANOLOCK? SURFACE TECHNOLOGY 2312-0314-N manufactured by Titan Spine.
[185976207]
Patient weight was not available. Other relevant device(s) are: product id: 2300-5530, serial/lot #: (b)(4), udi#: (b)(4); product id: 2300-5530, serial/lot #: (b)(4), udi#: (b)(4); product id: 2300-5530, serial/lot #: (b)(4), udi#: (b)(4). It was unable to be determined which of the three screws (product id: 2300-5530) was the screw that had backed out. The cage and three screws remained implanted in the patient. Therefore, no devices have been returned to the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185976208]
Medtronic received information regarding a spinal device. It was reported that a screw backed out of the cage post-operatively. The date of the primary surgery was (b)(6) 2019 and the date the reported issue occurred was (b)(6) 2019. The primary surgery was performed to treat a grade 1 mobile slip/isthmic spondylolisthesis. The levels implanted were l5/s1. The patient returned to the hospital a couple of weeks after the primary surgery with pain. It was confirmed by imaging that a screw had backed out. As a cage and three screws were used, the lot number of the individual screw that had backed out was unable to be identified. The patient was readmitted; the patient was backed up with posterior pedicle screws and a posterior fusion was completed to stop the movement of the cage. The cage and three screws remained implanted. It was noted that the screw that backed out was being monitored. As the case was not far enough out, fusion had not been assessed. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006340236-2020-00003 |
| MDR Report Key | 9826434 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-12 |
| Device Manufacturer Date | 2018-05-04 |
| Date Added to Maude | 2020-03-12 |
| 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 | TITAN SPINE |
| Manufacturer Street | 6140 W. EXECUTIVE DR. SUITE A |
| Manufacturer City | MEQUON WI 53092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSKELETON? TAS NANOLOCK? SURFACE TECHNOLOGY |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR |
| Product Code | OVD |
| Date Received | 2020-03-12 |
| Model Number | 2312-0314-N |
| Catalog Number | 2312-0314-N |
| Lot Number | TM0111721 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TITAN SPINE |
| Manufacturer Address | 6140 W. EXECUTIVE DR. SUITE A MEQUON WI 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |