MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-23 for AIO STERILIZATION CASE 6200-1220 manufactured by Zimmer Biomet Spine Inc..
[106247159]
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation. Reference reports 3012447612-2018-00361 thru 3012447612-2018-00365.
Patient Sequence No: 1, Text Type: N, H10
[106247160]
It was reported that a surgeon has seen patient infections after using an inserter and related implants which are stored in the same sterilization case. There is no specific infection cause or patient information available. This is report one of five.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2018-00361 |
| MDR Report Key | 7452797 |
| Date Received | 2018-04-23 |
| Date of Report | 2018-11-27 |
| Date Mfgr Received | 2018-11-27 |
| Device Manufacturer Date | 2013-02-15 |
| Date Added to Maude | 2018-04-23 |
| 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. GEOFFREY GANNON |
| Manufacturer Street | 10225 WESTMOOR DR. NA |
| Manufacturer City | WESTMINSTER CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | ZIMMER BIOMET SPINE INC. |
| Manufacturer Street | 10225 WESTMOOR DR. NA |
| Manufacturer City | WESTMINSTER CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AIO STERILIZATION CASE |
| Generic Name | TRAY, SURGICAL |
| Product Code | LRP |
| Date Received | 2018-04-23 |
| Returned To Mfg | 2018-04-12 |
| Model Number | NA |
| Catalog Number | 6200-1220 |
| Lot Number | L579404 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET SPINE INC. |
| Manufacturer Address | 10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-23 |