MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-04-25 for METHYL METHACRYLATE FOR CRANIPLASTY manufactured by Synthes (usa).
[73631310]
Additional patient identifier: (b)(6). Patient weight reported only as (b)(6). It is not known if it is pounds or kilograms. Date of infection is not known. This report is for an unknown cranios putty. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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. Device was used for treatment, not diagnosis. 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
[73631311]
It is reported patient suffered a lateral skull base cerebrospinal fluid (csf) leak and underwent surgery on (b)(6) 2016 in which cranios was used. Post-operatively, the csf leak appears to be repaired but the patient developed an infection. The infection caused a prolific inflammatory/granulation response that eroded into the lateral semicircular canal and vestibule of the inner ear, which caused complete unilateral hearing loss and vestibular dysfunction. This hearing loss and vestibular dysfunction is reported to be permanent. Patient also required intravenous (iv) antibiotics to fully clear the infection. Patient was returned to surgery on (b)(6) 2017 due to hearing loss, imbalance, and infection. The implants were removed; surgery was completed successfully with no delay. Patient status is not known. This report is for one (1) unknown cranios putty. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-11510 |
| MDR Report Key | 6520086 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-25 |
| Date of Report | 2017-03-30 |
| Date Mfgr Received | 2017-03-30 |
| Date Added to Maude | 2017-04-25 |
| 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 | MICHAEL COTE |
| 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 | METHYL METHACRYLATE FOR CRANIPLASTY |
| Product Code | GXP |
| Date Received | 2017-04-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-04-25 |