MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-17 for UNKNOWN_INSTRUMENTS_PRODUCT UNK_INS manufactured by Stryker Instruments-kalamazoo.
[183756856]
During a cochlear implant surgery at the user facility, it was reported that a metal ring had disassembled from the attachment, and was found seated around the bur, posing the risk of a small component being lost in a surgical site. There were no adverse consequences reported, and additional information has been requested from the user facility.
Patient Sequence No: 1, Text Type: D, B5
[188593103]
Follow-up report submitted to document device evaluation results. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[188593104]
During a cochlear implant surgery at the user facility, it was reported that a metal ring had disassembled from the attachment, and was found seated around the bur, posing the risk of a small component being lost in a surgical site. There were no adverse consequences reported. Upon follow up, the user facility was not able to provide any further information regarding the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00709 |
| MDR Report Key | 9842870 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-17 |
| 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 | MR. ZACH BAKER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_INSTRUMENTS_PRODUCT |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
| Product Code | HBE |
| Date Received | 2020-03-17 |
| Catalog Number | UNK_INS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |