MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-15 for COTTON-LORENZ LARYNGEAL PROSTHESIS 7MM N/A 06-1070 manufactured by Biomet Microfixation.
[97341957]
(b)(4). Device product code: fwn. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[97341958]
It was reported "the 7 mm cotton meyer stent was to thick. The surgeon struggled for over an hour and finally had to use the 7. 5 cotton meyer. The case has been extended now and exposed the child to longer then planned anesthesia. The hole in the center of the stent is too narrow for the surgeon to insert instrumentation. Another surgeon stepped in to assist in the case and the surgery was able to be completed successfully using a new stent and placing the instrumentation anterior to the stent. The patient did not experience any complications and has been discharged from the hospital. " no additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00031 |
| MDR Report Key | 7189211 |
| Date Received | 2018-01-15 |
| Date of Report | 2018-05-21 |
| Date of Event | 2018-01-03 |
| Date Mfgr Received | 2018-05-05 |
| Date Added to Maude | 2018-01-15 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COTTON-LORENZ LARYNGEAL PROSTHESIS 7MM |
| Generic Name | STENT |
| Product Code | FWN |
| Date Received | 2018-01-15 |
| Model Number | N/A |
| Catalog Number | 06-1070 |
| Lot Number | UNKNOWN |
| ID Number | (01)00841036025946 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-15 |