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 2020-01-24 for CONFIDENCE KIT, NO NEEDLES 283913000 manufactured by Medos International Sàrl Ch.
[176648986]
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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
[176648987]
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient was underwent an unknown surgery to stop the cement flow the pressure in the hydraulic pump is reduced by unscrewing the holder. While unscrewing the holder the inner thread got jammed. The inner piston got lifted out which resulted in the liquid to flow out. The inner piston was put back in place and complete the cement augmentation successfully. There were no fragments created. The surgery was delayed two minutes. There was no patient consequence. This is report 2 of 6 (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00453 |
| MDR Report Key | 9629188 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-06-11 |
| Date Added to Maude | 2020-01-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 02400 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INT SPINE |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 02400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFIDENCE KIT, NO NEEDLES |
| Generic Name | POLYMETHYLMETHACRYLATE BONE CEMENT |
| Product Code | NDN |
| Date Received | 2020-01-24 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 283913000 |
| Catalog Number | 283913000 |
| Lot Number | 244232 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |