MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-07-02 for FEN MIS CANNULA STRL 279726508 manufactured by Depuy Synthes Spine.
[112920864]
(b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10
[112920867]
(b)(6). During the surgery with viper 2 system, the patient went into the cardiac arrest, followed by the reanimation that was not successful. The patient was an older female, 85 years old, with bechterew disease. The surgery was almost finished at the time of the event, with all the screws inserted and finished vertebroplasty in 6 vertebral bodies. The 12 viper screws/innies, 2 titanium rods, 3 confidence cements. Or doctor provided a medical rationale that indicates the use of the product is in no way related to the reported event: the patient had preexisting medical conditions that could potentially result in the outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-50631 |
| MDR Report Key | 7655626 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-02 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-01-06 |
| Date Mfgr Received | 2018-06-07 |
| Date Added to Maude | 2018-07-02 |
| 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 | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | MEDOS INT SPINE |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEN MIS CANNULA STRL |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2018-07-02 |
| Model Number | 279726508 |
| Catalog Number | 279726508 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-07-02 |