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 2016-10-28 for CEMENT DISPENSER manufactured by Synthes Usa.
[58700332]
This device was used for treatment, not diagnosis. Patient id# (b)(6), year of birth 1933. This report is for one (1) unknown traumacem v+ cement kit. (b)(6). This report is for six (6) unknown traumacem v+ cement kit. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[58700333]
Device report from synthes (b)(4) reports an event as follows: it was reported that the patient was implanted with nine (9) screws and four (4) were augmented; for a philos with augmentation procedure on (b)(6) 2015. The patient recovered without persistent damage by (b)(6) 2016. Post-operatively six months to a year the patient fell during the holidays. It was discovered that a mal-union had occurred with the philos with augmentation during an unknown time. This report is for one (1) unknown traumacem v+ cement kit. This report is 2 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2016-15105 |
| MDR Report Key | 6065289 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-28 |
| Date of Report | 2016-10-10 |
| Date Mfgr Received | 2016-10-10 |
| Date Added to Maude | 2016-10-28 |
| 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 | MARK VORNHEDER |
| 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 | CEMENT DISPENSER |
| Product Code | OAR |
| Date Received | 2016-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-10-28 |