BLOCKER HOLDER Adverse Event — Malfunction (MDR 3003853072-2020-00024)
BLOCKER HOLDER Adverse Event — Malfunction (MDR 3003853072-2020-00024) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BLOCKER HOLDER; Generic name: INSTINCT JAVA SYSTEM; Manufacturer: ZIMMER SPINE.
| Device | BLOCKER HOLDER |
|---|---|
| Generic name | INSTINCT JAVA SYSTEM |
| Manufacturer | ZIMMER SPINE |
| Report number | 3003853072-2020-00024 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | CMP-(B)(6). D4: UDI # (B)(4). G3: FOREIGN CHINA. THE COMPLAINT IS CONFIRMED FOR THE FAILURE OF DEFORMED TIP. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. ROOT CAUSE WAS UNABLE TO BE DETERMINED. PER DHR REVIEW, THE PARTS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. IF ANY FURTHER INFO |
| Source | openFDA MAUDE (device adverse events) |
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