MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-28 for 2.4 X 5.0MM SELF TAPPING SCREW 14-523080 manufactured by Zimmer Biomet Spine Inc..
[78909779]
Device product code: nqw. Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. Reference reports 3012447612-2017-00187 and 3012447612-2017-00189 thru 3012447612-2017-00199.
Patient Sequence No: 1, Text Type: N, H10
[78909780]
It was reported that (b)(4) screws appeared to be the wrong color upon receipt. The screws should be green, but appeared to be yellow. There was no surgery or patient associated with this event. This is report four of twelve for this event.
Patient Sequence No: 1, Text Type: D, B5
[133119765]
The returned screws were examined. The color was found to meet specifications. The complaint could not be confirmed. A review of the manufacturing records did not identify any issues which would have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012447612-2017-00191 |
| MDR Report Key | 6675812 |
| Date Received | 2017-06-28 |
| Date of Report | 2017-08-08 |
| Date Mfgr Received | 2017-08-03 |
| Device Manufacturer Date | 2016-11-28 |
| Date Added to Maude | 2017-06-28 |
| 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 | 2.4 X 5.0MM SELF TAPPING SCREW |
| Generic Name | GALLERY LAMINOPLASTY FIXATION SYSTEM |
| Product Code | NQW |
| Date Received | 2017-06-28 |
| Returned To Mfg | 2017-07-12 |
| Model Number | NA |
| Catalog Number | 14-523080 |
| Lot Number | B028 |
| ID Number | (01)00888480454977(10)B028 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-06-28 |