MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-11 for manufactured by Synthes Usa.
[3486119]
A hospital in (b)(6) reported the replacement of a hook. The surgeon replaced the proximal hook of hybrid type from the right fourth rib to the second lumbar vertebra to one from the fourth rib to the fifth rib. One blue clip and two gold ones were used. From the doctor's point of view this problem was rotation out of the hook. There is not a defect and health hazard in this surgery. The doctor can? T identify the reason due to shakeout of the rib, he thinks this issue involved flaccidness of the patient? S bone. This report is 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10838361]
Device is used for treatment, not diagnosis cannot be determined without a part number investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided. Manufacturing records could not be reviewed without a lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-03291 |
| MDR Report Key | 3163408 |
| Report Source | 01,07 |
| Date Received | 2013-06-11 |
| Date of Report | 2013-05-14 |
| Date of Event | 2012-06-25 |
| Date Mfgr Received | 2013-05-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JODI TEMPLE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | KIK |
| Date Received | 2013-06-11 |
| 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 | 2013-06-11 |