MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-05-06 for ARTELON CMC SPACER manufactured by Artimplant Ab.
[3441070]
Explantation of artelon cmc spacer due to increasing pain at activity. The patient had been pain free and functional until approx 18 months after implant surgery. X-rays revealed recurrent osteophytes. (same patient as 3004878714-2013-00014). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10871119]
Explant sent to histology. No result yet.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004878714-2013-00013 |
| MDR Report Key | 3161565 |
| Report Source | 07 |
| Date Received | 2013-05-06 |
| Date Mfgr Received | 2013-05-07 |
| Date Added to Maude | 2013-06-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | HULDA MELLGRENS GATA 5 |
| Manufacturer City | V. FROLUNDA SE-421 32 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-421 32 |
| Manufacturer Phone | 17465600 |
| Manufacturer G1 | ARTIMPLANT AB |
| Manufacturer Street | HULDA MELLGRENS GATA 5 |
| Manufacturer City | V. FROLUNDA SE-421 3 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-421 32 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTELON CMC SPACER |
| Generic Name | SPACER |
| Product Code | KYI |
| Date Received | 2013-05-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTIMPLANT AB |
| Manufacturer Address | HULDA MELLGRENS GATA 5 V. FROLUNDA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-06 |