MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-20 for MIS TI CFX FEN POLY 9X80 186727980 manufactured by Medos International Sàrl Ch.
[131930736]
(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
[131930737]
It was reported that the patient operated with expedium 5. 5 ca 1 year ago. The rod had slipped out of the patient, leaving the construction not satisfying. Patient was fine for the first months after first surgery. Then after a while he got more back problem again. Reoperation shows that some of the sets screw on the distal part of the construction was not that hard to open(seemed like they where not as tight as they should be, final tightening was done by doctors during surgery first time). On the right side the rod was just inside the distal screw, almost on it-s way out as well. Construction was from l2 to s1 with ilium screws bilat. The one ilium screw the whole tulip just had loosen from it screw and was hanging on the rod, without being on the screw itself. During surgery (today) they where tapping with a 10 mm tap before putting in 10x80 viper cortical fix screw in the old ilium fixation (they took out 9x80) the two polyaxial screw driver broke , and the viper screwdriver. The viper part got stuck in the screw while it was half way in the bone, they tried to take i out, but with no luck, leaving it to no other chose than saw of the part that was outside the bone, leaving the rest in the patient. Then they took a exp verse below that (8x80) with success. Final tightening after rod insertion. Some of the sets screws that was taken out had some marks on them. I am sending in all materials from surgery, and was in patient from surgery number 1 as well. Patient consequence? Unknown. Patient consequence description: longer surgery, reoperation from first surgery. Is the information being submitted for this complaint all the details that are known/available regarding this event? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-51169 |
| MDR Report Key | 8185914 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2016-05-26 |
| Date Added to Maude | 2018-12-20 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| 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 9X80 |
| Generic Name | BONE CEMENT, POSTERIOR SCREW AUGMENTATION |
| Product Code | PML |
| Date Received | 2018-12-20 |
| Returned To Mfg | 2019-01-09 |
| Model Number | 186727980 |
| Catalog Number | 186727980 |
| Lot Number | AVFDR7 |
| 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 | 2018-12-20 |