MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-14 for CRANIOFIX 2 TITANIUM CLAMP 16MM FF491T manufactured by Aesculap Ag.
[127145874]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[127145875]
It was reported that during an initial neurosurgery procedure on a patient on (b)(6) 2018, the surgeon used two ff491t and one ff490t for the three point fixation of the skull. After surgery it was found that the bone flap had detached from the skull at the horsehead, looseness was seen where one ff491t was placed. On (b)(6) 2018, due to the dislocated bone flap, a revision surgery was performed to fix the bone flap. Two ff491t's and two ff490t's were used to secure the bone flap. Additional mfr report #: 9610612-2018-00495. Components in use listed are: ff490t (2).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00494 |
| MDR Report Key | 8070943 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-10-05 |
| Date Facility Aware | 2018-10-22 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2018-03-26 |
| Date Added to Maude | 2018-11-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | CRANIOFIX 2 TITANIUM CLAMP 16MM |
| Generic Name | CRANIAL IMPLANTS |
| Product Code | GXR |
| Date Received | 2018-11-14 |
| Returned To Mfg | 2018-10-29 |
| Model Number | FF491T |
| Catalog Number | FF491T |
| Lot Number | 52417783 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-14 |