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 |