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 2019-05-17 for MIS TI CFX FEN POLY 6X40 186727640 manufactured by Medos International Sàrl Ch.
[145416628]
(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
[145416629]
It was reported that the patient underwent 1st surgery on (b)(6) 2018, fusion l5-s1 with expedium and t-pal. On (b)(6) 2018, revision surgery because of radiculopathy and suspicion on infection. Implants where loose, have been removed and replaced. Post op pain free. Tissue has been examined in bacteriology, one sample was positive. Patient showed up in (b)(6) with back pain, examinations have shown again pseudarthrosis and loosening of the implants. On (b)(6), again revision surgery, removal of all implants, which have been sent in for bacteriological examination. Several tissue samples will also be examined bacteriologically. T-pal cage will be removed from anterior after these results of the bacteriological examination are known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51652 |
| MDR Report Key | 8620869 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-17 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-29 |
| Date Mfgr Received | 2019-07-17 |
| Device Manufacturer Date | 2018-12-03 |
| Date Added to Maude | 2019-05-17 |
| 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 6X40 |
| Generic Name | BONE CEMENT, POSTERIOR SCREW AUGMENTATION |
| Product Code | PML |
| Date Received | 2019-05-17 |
| Returned To Mfg | 2019-06-04 |
| Model Number | 186727640 |
| Catalog Number | 186727640 |
| Lot Number | 226187 |
| 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 | 1. Required No Informationntervention | 2019-05-17 |