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 2019-01-18 for METHYL METHACRYLATE FOR CRANIPLASTY manufactured by Wrights Lane Synthes Usa Products Llc.
[133687894]
There are multiple patients. All known information is provided in the journal article. 510k: this report is for an unknown cranios calcium phosphate cement /unknown lot. Part and lot number are unknown; udi number is unknown. There are multiple dates of implantation between march 2013 and december 2015. 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. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. (b)(4). 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[133687895]
This report is being filed after the review of the following journal article: feroze, ra. , agarwal, n. And sekula, rf. (2018), utility of calcium phosphate cement cranioplasty following supraorbital approach for tumor resection, international journal of neuroscience, pages 1-6 (usa). The aim of this retrospective analysis study of a prospectively maintained database is to demonstrate the efficacy of calcium phosphate cement cranioplasty following a supraorbital approach for tumor resection. Between march 2013 and december 2015, a total of 8 patients (1 male and 7 female) with a mean age of 67 years (range, 55-82 years) underwent a supraorbital approach followed by cement cranioplasty. To achieve a watertight, calcium phosphate cement cranioplasty, 10 ccs of sodium hyaluronate solution was vigorously mixed with 17 grams of calcium phosphate powder in a sterile fashion for 45-90 seconds, resulting in a moldable paste (cranios reinforced, synthes; 74 hydroset, stryker). The cohort had a mean follow-up of approximately 3. 1 months (range, 0. 5-7 months). The following complications were reported: a (b)(6) female required revision surgery for residual tumor. 2 patients required readmissions for surgical revision. This report is for an unknown synthes calcium phosphate cement (cranios reinforced). This is report 1 of 1 for (b)(4). A copy of the literature article is being submitted with this medwatch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-55933 |
| MDR Report Key | 8261423 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-18 |
| Date of Report | 2018-12-27 |
| Date Mfgr Received | 2018-12-27 |
| Date Added to Maude | 2019-01-18 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| 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 | 2019-01-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-18 |