MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for 6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM FF017 manufactured by Aesculap Implant Systems.
[106715210]
(b)(4). Manufacturing site evaluation: evaluation on-going
Patient Sequence No: 1, Text Type: N, H10
[106715231]
(b)(6). Suture knot did not work and disks was not fixed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00204 |
| MDR Report Key | 7462962 |
| Date Received | 2018-04-25 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-04-04 |
| Date Facility Aware | 2018-04-23 |
| Date Mfgr Received | 2018-04-05 |
| Device Manufacturer Date | 2017-11-22 |
| Date Added to Maude | 2018-04-25 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM |
| Generic Name | RANIOFIX RESORBABLE IMPLANTS |
| Product Code | HTT |
| Date Received | 2018-04-25 |
| Returned To Mfg | 2018-04-16 |
| Model Number | FF017 |
| Catalog Number | FF017 |
| Lot Number | 52375009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP IMPLANT SYSTEMS |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-25 |