MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-05-08 for 130 DEG 4-HOLE RIGHT NECK FX N/A 14-451104 manufactured by Zimmer Biomet, Inc..
[107560480]
(b)(4). Multiple mdr's were reported for this event. Please also see associated events: 0001825034 - 2018 - 03234, 0001825034 - 2018 - 03236. This report is being submitted late as it has been identified in remediation. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no furth er action is required as no were trends identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[107560481]
It was reported the patient experienced post operative pain. Attempts have been made and no further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-03235 |
| MDR Report Key | 7493599 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-05-08 |
| Date of Report | 2018-05-07 |
| Date of Event | 2016-04-29 |
| Date Mfgr Received | 2016-05-03 |
| Device Manufacturer Date | 2015-06-30 |
| Date Added to Maude | 2018-05-08 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 130 DEG 4-HOLE RIGHT NECK FX |
| Generic Name | DEVICE, FIXATION |
| Product Code | JDO |
| Date Received | 2018-05-08 |
| Model Number | N/A |
| Catalog Number | 14-451104 |
| Lot Number | 479380 |
| ID Number | (01) 00887868164385 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 14 | 1. Other | 2018-05-08 |