MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-04 for UNKNOWN OTHER PRODUCTS manufactured by Medos International Sàrl Ch.
[129297274]
(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
[129297275]
Per reporter, unknown to ourselves interventional radiology were attempting a vertebroplasty, when we received a call from dr (b)(6) to come immediately as a 11g bevelled tip confidence needle had snapped in the patient. As i got the department patient was taken to day ward to wait for a theatre slot to have the needle removed as told by dr (b)(6). Speaking to dr (b)(6) i tried to gather information of how this happened but his response was that it just snapped like the others that have snapped in the past. I informed him that our product manager (ant avery) was available via phone to discuss case but he refused to talk to anyone and just said he would not be using our products again. Later i had the chance to discuss the case with interventional radiology staff and was asking how the needle snapped and was the stylet used when advancing the needle, their response was that to their knowledge the stylet was used and dr (b)(6) said the needle snapped after the cement had be delivered and when he was removing the needle from the vertebral body at the end of the procedure. The patient later in the day was sent to main theatre to have it surgically removed, i was present for this procedure and with difficulty as the cement had set, the surgeon was able to remove the part of the stylet that was protruding the pedicle whilst having to leave the remain part of the stylet in the pedicle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-51124 |
| MDR Report Key | 8130015 |
| Date Received | 2018-12-04 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2019-02-11 |
| Date Added to Maude | 2018-12-04 |
| 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 | 0 |
| Brand Name | UNKNOWN OTHER PRODUCTS |
| Generic Name | UNKNOWN |
| Product Code | OAR |
| Date Received | 2018-12-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-12-04 |