MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for RAPID RESORBABLE CRANIAL CLAMP 18MM 851.801.01S manufactured by Wrights Lane: Synthes Usa Products Llc.
[98169010]
This report is for an unknown number of unknown clamps - unknown lot. Additional procode hbw. Complainant part has not been 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
[98169031]
It was reported that there were reports of breakage of the implant during implantation from a survey by the clinical team filled out by one surgeon who had used the rapidsorb cranial clamp. The actual number of cases that these malfunctions have occurred in is unknown. This is because based on the survey design, the percentages of malfunctions and adverse events are as per the surgeon's perception and may not be an actual calculated number. The surgeon has been involved in at least twenty-one (21) surgeries of children with the rapidsorb cranial clamp. This complaint involves one (1) device. This report is for an unknown number of clamps. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-50305 |
| MDR Report Key | 7205459 |
| Date Received | 2018-01-19 |
| Date of Report | 2017-12-21 |
| Date Mfgr Received | 2018-02-14 |
| Date Added to Maude | 2018-01-19 |
| 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 Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | OBERDORF : SYNTHES PRODUKTIONS GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RAPID RESORBABLE CRANIAL CLAMP 18MM |
| Generic Name | COVER, BURR HOLE |
| Product Code | HBW |
| Date Received | 2018-01-19 |
| Model Number | 851.801.01S |
| Catalog Number | 851.801.01S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-01-19 |