MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-10-28 for MICROFRANCE? INSTRUMENT CP845 manufactured by Medtronic Xomed Instrumentation S.a.s.
[5149582]
It was reported that the device broke during surgery. There was no reported impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[12443838]
Blank fields on this report are the result of information not being provided by initial reporter. This device is used for therapeutic purposes. (b)(4). The product analysis determined? The elevator is broken next to the tig welding area. There is no missing fragment.? Results: fracture problem. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31983332]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00089 |
| MDR Report Key | 4206066 |
| Report Source | 01,05,07 |
| Date Received | 2014-10-28 |
| Date of Report | 2014-10-07 |
| Date Mfgr Received | 2014-11-04 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2014-11-07 |
| 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 Contact | AMY CORRALES |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32205 |
| Manufacturer Country | US |
| Manufacturer Postal | 32205 |
| Manufacturer Phone | 9043328138 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32205 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROFRANCE? INSTRUMENT |
| Generic Name | ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GEG |
| Date Received | 2014-10-28 |
| Returned To Mfg | 2014-10-07 |
| Model Number | CP845 |
| Catalog Number | CP845 |
| Lot Number | 120901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INSTRUMENTATION S.A.S |
| Manufacturer Address | LE PAVILLON SAINT-AUBIN-LE-MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-28 |