MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-03-25 for ARELTON CMC SPACER manufactured by Artimplant Ab.
[18623790]
An artelon cmc spacer was explanted on (b)(6) 2012 due to alleged injury. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18704961]
Investigation based on lawsuit documents filed against artimplant (b)(4) and artimplant us, inc. No information supporting the allegations of lawsuit currently available. Report delayed due to internal administrative mistake.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004878714-2013-00006 |
| MDR Report Key | 3037363 |
| Report Source | 00 |
| Date Received | 2013-03-25 |
| Date of Report | 2013-03-20 |
| Date of Event | 2012-03-08 |
| Date Mfgr Received | 2012-12-21 |
| Date Added to Maude | 2013-04-08 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | HULDA MELLGRENS GATA 5 |
| Manufacturer City | VASTRA FROLUNDA SE-421 32 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-421 32 |
| Manufacturer Phone | 17465600 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARELTON CMC SPACER |
| Generic Name | SPACER |
| Product Code | KYI |
| Date Received | 2013-03-25 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTIMPLANT AB |
| Manufacturer Address | VASTRA FROLUNDA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2013-03-25 |