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 2020-02-11 for CD HORIZON SOLERA FENESTRATED SCREW SPINAL SYSTEM 55840027560 manufactured by Mdt Sofamor Danek Puerto Rico Mfg.
[187388101]
Outcomes to adverse event: other - lower lumbar pain. Pma/510k: this part is not approved for use in the united states; however, a like device catalog # 55840025550t, 510k# k152604 and udi# (b)(4) was cleared in the united states. Product was not 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
[187388102]
It was reported that the patient underwent posterior lumbar instrumentation from l3 to s1 with l5 reduction due to lumbar spondylosis. Post-op, head(tulip) of the implanted screw had been detached from screw shaft due to this patient experienced increased lower lumbar pain. Patient underwent revision surgery for the removal of alleged screw.
Patient Sequence No: 1, Text Type: D, B5
[187796465]
X-ray review results: post-op x-ray ap/lateral l4-s1 fusion provided. By report this was l3-s1 but no instrumentation is present at l3. One of the s1 screw shows detachment of the screw head from the shank. No interbody device is present, fusion status is unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2020-00163 |
| MDR Report Key | 9691596 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-11 |
| Date of Report | 2020-04-01 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2016-09-16 |
| Date Added to Maude | 2020-02-11 |
| 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 | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Manufacturer Street | BARRIO MARIANNA RD 909, KM0.4 |
| Manufacturer City | HUMACAO PR 00792 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00792 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CD HORIZON SOLERA FENESTRATED SCREW SPINAL SYSTEM |
| Generic Name | ORTHOSIS, SPINAL PEDICLE FIXATION |
| Product Code | MNI |
| Date Received | 2020-02-11 |
| Model Number | NA |
| Catalog Number | 55840027560 |
| Lot Number | H5307049 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Manufacturer Address | BARRIO MARIANNA RD 909, KM0.4 HUMACAO PR 00792 US 00792 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-02-11 |