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 2020-01-14 for CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE 615.10.01S manufactured by Wrights Lane Synthes Usa Products Llc.
[188228369]
Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). A device history record (dhr) review was conducted: manufacturing location: supplier - dsm biomedical (b)(4). Expiration date: 28-aug-2017. Part number: 615. 10. 01s, cranios reinforced fast set putty 10cc? Sterile. Lot number: dsd3815 (sterile). Lot quantity: (b)(4). Purchased finished goods traveler met all inspection acceptance criteria. Inspection sheet, incoming final inspection, (b)(4) rev m met all inspection acceptance criteria. Certificate of conformance received from dsm dated 07-may-2016 was reviewed and determined to be conforming. Sterility requirements on certificate were reviewed and determined to be conforming. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition. 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. 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
[188228370]
It was reported that on (b)(6) 2018, the patient underwent removal of bone cement due to cement fragmentation and infection that was known on (b)(6) 2017. Findings at last follow-up temporal retrusion right, left posterior skull bony contour irregularities. The patient participates in martial arts and notes repeated trauma to the head and, over the past several months, had noted some boggy inflammation in the right forehead region without frank infection. More recently, it developed a small abscess on the upper lid on the right, suggesting some sort of infection of the alloplast, which had presumed to be traumatically fragmented, had chronic inflammation and fragmentation of the phosphate cement both on the right and left temporal regions. It appears that the patient had this with an infection through the right upper lid. The original implant date was on (b)(6) 2016. It is unknown if there was a surgical delay. The procedure and patient outcomes were unknown. This report is for one (1) cranios reinforced fast set putty 10cc-sterile this is report 1 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00175 |
| MDR Report Key | 9587247 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-17 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2016-05-16 |
| Date Added to Maude | 2020-01-14 |
| 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 |
| 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 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE |
| Generic Name | METHYL METHACRYLATE FOR CRANIPLASTY |
| Product Code | GXP |
| Date Received | 2020-01-14 |
| Model Number | 615.10.01S |
| Catalog Number | 615.10.01S |
| Lot Number | DSD3815 |
| Device Expiration Date | 2017-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-14 |