MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-04-18 for ST360 POLYAXIAL SCREW 6.5 X 45MM 07.00319.035 manufactured by Zimmer Spine.
[3344827]
Same case as 2184052-2013-00018. It was reported that screw breakage occurred postoperatively. The index surgery treated l5-s1 for a pars defect, spondylolithesis grade 1/spondylosis and bilateral leg pain. At a one year follow-up a ct scan noted a fractured screw at the right s1; the pt was asymptomatic. One year after this, the pt presented with discomfort on the right side. Ct scan showed left s1 screw was also fractured. The pt chose to have the screws removed even though the surgeon noted no movement. The entire construct was removed and the pt was used with bone.
Patient Sequence No: 1, Text Type: D, B5
[10714644]
Additional relevant information will be provided when the device eval is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184052-2013-00019 |
| MDR Report Key | 3074791 |
| Report Source | 08 |
| Date Received | 2013-04-18 |
| Date of Report | 2013-03-28 |
| Date of Event | 2013-03-21 |
| Date Mfgr Received | 2013-04-01 |
| Date Added to Maude | 2013-06-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT LAPOINTE |
| Manufacturer Street | 7375 BUSH LAKE RD. |
| Manufacturer City | MINNEAPOLIS MN 55439 |
| Manufacturer Country | US |
| Manufacturer Postal | 55439 |
| Manufacturer Phone | 9528325600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ST360 POLYAXIAL SCREW 6.5 X 45MM |
| Generic Name | ST360 POLYAXIAL SCREW 6.5 X 45MM |
| Product Code | MCV |
| Date Received | 2013-04-18 |
| Returned To Mfg | 2013-04-05 |
| Model Number | 07.00319.035 |
| Catalog Number | 07.00319.035 |
| Lot Number | 61626591 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE |
| Manufacturer Address | 7375 BUSH LAKE RD. MINNEAPOLIS MN 55439 US 55439 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-18 |