MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-11-05 for MIS TI CFX FEN POLY 7X50 186727750 manufactured by Medos International Sàrl Ch.
[128211746]
(b)(4). Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation 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
[128211747]
It was reported surgeon was revising an old spinal fusion. When he went to replace the old hardware with new hardware, the driver tips sheared while he was inserting the screws. This happened on multiple levels with different size screws. Surgeon tapped before inserting screws. Patient consequence? :yes. Patient consequence description:increased anesthesia time. On (b)(6) 2018: additional information confirmed by rep: all 5 tips broke. Tips are retained in the screws. Surgical delay of approximately 30 mins to an hour.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-51052 |
| MDR Report Key | 8039770 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-11-05 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2018-12-31 |
| Device Manufacturer Date | 2017-03-21 |
| Date Added to Maude | 2018-11-05 |
| 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 | 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 | MIS TI CFX FEN POLY 7X50 |
| Generic Name | BONE CEMENT, POSTERIOR SCREW AUGMENTATION |
| Product Code | PML |
| Date Received | 2018-11-05 |
| Returned To Mfg | 2018-10-30 |
| Model Number | 186727750 |
| Catalog Number | 186727750 |
| Lot Number | 124867 |
| 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 | 2018-11-05 |