MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-07-30 for DVR LOCK NARROW MINI R N/A 131811040 manufactured by Zimmer Biomet, Inc..
[152811169]
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[152811170]
It was reported that during procedure a k-wire got stuck in one of the holes of dvr crosslock plate and could not be removed. The procedure was completed using another plate. No adverse event to patient reported. No more information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-03272 |
| MDR Report Key | 8843800 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-07-30 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-07-05 |
| Date Mfgr Received | 2019-07-05 |
| Date Added to Maude | 2019-07-30 |
| 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 | DVR LOCK NARROW MINI R |
| Generic Name | PROSTHESIS, TRAUMA |
| Product Code | LXT |
| Date Received | 2019-07-30 |
| Returned To Mfg | 2019-07-16 |
| Model Number | N/A |
| Catalog Number | 131811040 |
| Lot Number | J6464253 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 0 | 2019-07-30 |