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.
[127144736]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[127144737]
Revision surgery was performed on (b)(6) 2018, due to the dislocated bone flap. Two ff491t's and two ff490t's were used to secure the bone flap. Again, the bone flap dislocated at the same area where the bone flap was revised at the ff490t. It seemed the free bone flap went up and not sliding to the side. A ct scan was taken on (b)(6) 2018 that showed significant dislocation of the bone flap. A revision surgery was performed on (b)(6) 2018 and all four of the craniofix's were removed and were sent for investigation. All med watch submissions related to this patient are: 9610612-2018-00494. Components in use listed are: ff490t (2).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00495 |
| MDR Report Key | 8070938 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-10-16 |
| Date Facility Aware | 2018-10-22 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2018-03-21 |
| 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 | 52417148 |
| 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 |