MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-07 for EXPEDIUM 279726500 manufactured by Depuy Synthes Spine.
[92330647]
A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[92330648]
The surgeon was performing a l1-l5 posterior lumbar fusion with expedium ti 5. 5mm rod system and viper fenestrated screw system (expedium l2, l3, l4, and l5 / viper fenestrated @ l1). The surgeon elected to not use the alignment guide for cement placement with the fenestrated screws at left l1 screw. I warned him that the system was intended to be used with the alignment guides. He elected to proceed without the alignment guide. While directly placing the viper fenestrated open cannula into the left l1 viper fenestrated screw, the tip of the cannula broke off while the surgeom started deploying the cement. He stopped after the cannula broke. He then used the alignment guide on the right l1 screw and completed the cement fill on this side. He then performed a t12 open vertebroplasty with the remaining confidence cement. He then removed the left l1 viper fenestrated screw that contained the tip of the cannula. He replaced this screw with a standard expedium screw. He then successfully completed the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2017-10952 |
| MDR Report Key | 7005872 |
| Date Received | 2017-11-07 |
| Date of Report | 2017-10-12 |
| Date of Event | 2017-10-12 |
| Date Mfgr Received | 2017-10-12 |
| Date Added to Maude | 2017-11-07 |
| 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 | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808201 |
| Manufacturer G1 | MEDOS INTERNATIONAL SARL |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE CH-2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EXPEDIUM |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2017-11-07 |
| Model Number | 279726500 |
| Catalog Number | 279726500 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-07 |