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 2017-11-14 for RAPID RESORBABLE CRANIAL CLAMP18MM 851.801.01S manufactured by Synthes Oberdorf.
[92034245]
(b)(6). Additional product code: gxr. (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. Dhr review was completed. Manufacturing location: (b)(4). Manufacturing date: 30. Nov. 2016 expiry date: 01. Jul. 2020. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[92034246]
It was report that the patient had a cranioplasty procedure on (b)(6) 2017 for treatment of a subdural hematoma. Patient was implanted with seven (7) 18mm rapid resorbable cranial clamps, to reattach the cranial bone flap that was previously removed due to the subdural hematoma on an unknown date. On an unknown date post-operatively, patient presented with an infection. On (b)(6) 2017, surgeon removed all seven (7) resorbable implants. It was reported that no fragments were generated during implant removal. Revision surgery was completed successfully with no time delay. Patient is reported in stable condition. This report is for one (1) rapid resorbable cranial clamp 18mm. This is report 1 of 7 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2017-16206 |
| MDR Report Key | 7029467 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-14 |
| Date of Report | 2017-10-20 |
| Date Mfgr Received | 2017-10-20 |
| Device Manufacturer Date | 2016-11-30 |
| Date Added to Maude | 2017-11-14 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES OBERDORF |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF CH4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID RESORBABLE CRANIAL CLAMP18MM |
| Generic Name | FASTENER PLATE,CRANIOPLASTY |
| Product Code | HBW |
| Date Received | 2017-11-14 |
| Catalog Number | 851.801.01S |
| Lot Number | L157718 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES OBERDORF |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF CH4436 SZ CH4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-14 |