MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-06 for CERVICAL CURETTE manufactured by Symmetry Surgucal Inc.
[148273050]
The product code and lot number is unknown as the product code has been rubbed off the instrument, however the customer also reported that the instrument is over 20 years old. The customer will be returning the device and we will be able to determine the cup size and part number. Once we have obtained additional information, a follow-up report will be submitted. (b)(6). (b)(4). The delay in the fda receiving this complaint was due to a change in e-signature certificates.
Patient Sequence No: 1, Text Type: N, H10
[148273051]
During a cervical spine surgery, the tip of the curette broke off and fell into the patient. The piece was successfully removed with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2019-00008 |
| MDR Report Key | 8676188 |
| Date Received | 2019-06-06 |
| Date of Report | 2019-03-19 |
| Date of Event | 2018-12-02 |
| Date Mfgr Received | 2019-02-27 |
| Date Added to Maude | 2019-06-06 |
| 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 | BRANDI MEATH |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer G1 | SYMMETRY SURGICAL INC |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | CERVICAL CURETTE |
| Product Code | FZS |
| Date Received | 2019-06-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGUCAL INC |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-06 |