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 2018-05-02 for DISPENSER, CEMENT manufactured by Oberdorf Synthes Produktions Gmbh.
[107097177]
Patient information is not available for reporting. Event year reported as 2018; exact date is unknown. This report is for an unknown biomaterial - cement delivery device. Part and lot numbers are unknown. Without the specific part and lot number, the udi is not available. Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter? S phone number is not provided for reporting. (510k): unknown, as specific part and lot numbers for cement delivery device is not provided. (b)(4) used to capture additional medical/surgical intervention required: the cement hardened too quickly preventing the injection device from being removed. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device was used for treatment, not diagnosis. 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
[107097178]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during augmentation of tfn-advanced? Proximal femoral nailing system (tfna), the traumacem cement hardened quite fast. Because of this it was impossible to remove the cement cannula. It broke and a part of the cannula remained in the blade. No other information provided. Concomitant device reported: blade (part # unknown, lot # unknown, quantity 1). This report is for an unknown biomaterial - cement delivery device. This is report 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-53493 |
| MDR Report Key | 7479391 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-02 |
| Date of Report | 2018-04-03 |
| Date Mfgr Received | 2018-04-03 |
| Date Added to Maude | 2018-05-02 |
| 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 | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2018-05-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-02 |