MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-14 for ELECTRODE CABLE manufactured by Synthes Usa.
[91934016]
Device used for treatment, not diagnosis. (b)(6). Patient dob and weight not provided for reporting. This report is for unknown cable/wire/unknown lot number. Device is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided. 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
[91934017]
Device report from synthes on an event in (b)(6) as follows: it was reported that the patient had redness and pain after the initial open reduction and internal fixation surgery (orif) rx washout distal end and insertion of stimulant. No growth and the patient was fine after, presumed not infected, samples also all negative at revision. Post-operative the plate broke (b)(4). This complaint involves 5 parts. This report is 3 of 5 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-12637 |
| MDR Report Key | 7028349 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-14 |
| Date of Report | 2017-10-18 |
| Date Mfgr Received | 2017-10-18 |
| Date Added to Maude | 2017-11-14 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ELECTRODE CABLE |
| Product Code | IKD |
| Date Received | 2017-11-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-14 |