MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for CD HORIZON SPINAL SYSTEM UNK manufactured by Medtronic Sofamor Danek.
[47649661]
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. However, applicable imaging studies were returned to the manufacturer for evaluation, whose review is as follows: "l5-s1 construct screws show probable bilateral s1 screw breakage. A spondylolisthesis is present. There is no interbody graft. It is unknown what the degree of reduction of the spondylolisthesis was immediately post-op. An interbody graft may help with deformity reduction and fusion. Fusion status is unknown. Root cause indeterminate. "
Patient Sequence No: 1, Text Type: N, H10
[47649662]
It was reported that the patient underwent spinal fusion from l5 to s1 due to spondylolisthesis (grade 1) / spinal stenosis. Post-op, on an unknown date, (after 3 months), both the s1 level screws were visibly broken at the 4th or 5th thread. Patient was currently doing physiotherapy. The screws were still inside the patient. Reportedly, the patient was overall doing fine.
Patient Sequence No: 1, Text Type: D, B5
[100604595]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2016-01616 |
| MDR Report Key | 5694472 |
| Date Received | 2016-06-02 |
| Date of Report | 2016-05-04 |
| Date Mfgr Received | 2016-05-04 |
| Date Added to Maude | 2016-06-02 |
| 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 | GREG ANGLIN |
| 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 | 0 |
| Brand Name | CD HORIZON SPINAL SYSTEM |
| Product Code | OSH |
| Date Received | 2016-06-02 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-02 |