MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for RAPID RESORBABLE CRANIAL CLAMP 18MM 851.801.01S manufactured by Oberdorf Synthes Produktions Gmbh.
[127367251]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Additional product code: hbw. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). The investigation could not be completed; no conclusion could be drawn. 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.
Patient Sequence No: 1, Text Type: N, H10
[127367252]
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2018, that a craniotomy procedure was performed and the rapid resorbable cranial clamp broke during the surgery. The broken rapid resorbable cranial clamp was replaced to complete the procedure. It is unknown if there was a surgical delay. There was no reported adverse event in the patient. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-58160 |
| MDR Report Key | 8065873 |
| Date Received | 2018-11-13 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2018-04-19 |
| Date Added to Maude | 2018-11-13 |
| 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 | MR. KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA |
| Manufacturer Country | SZ |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK BIO OBERDORF (CH) |
| 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 | GXR |
| Date Received | 2018-11-13 |
| Returned To Mfg | 2018-12-04 |
| Catalog Number | 851.801.01S |
| Lot Number | L703891 |
| Device Expiration Date | 2018-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-13 |