MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-05-16 for manufactured by Synthes Usa.
[15770393]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: during a procedure on an unknown date, an ala hook broke on the left side in the patient on the shaft just below where the connector was placed. One part was removed, the other part remained inside the patient. The surgeon implanted a new connector that he placed on the remaining ala hook to connect with the existing rod construct. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[15979212]
Device was used for treatment, not diagnosis. Without a lot number, the device history records review could not be completed. The investigation could not completed; no conclusion could be drawn, as no product was received. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-02603 |
| MDR Report Key | 3115335 |
| Report Source | 01,07 |
| Date Received | 2013-05-16 |
| Date of Report | 2013-04-18 |
| Date Mfgr Received | 2013-04-18 |
| Date Added to Maude | 2013-05-16 |
| 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 | ADAM SHUKUR |
| 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 | 2013-05-16 |
| 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 | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-16 |