MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for PLASMAX PLUS COUNTERBALANCE 800-0512 manufactured by Zimmer Biomet, Inc..
[146349038]
(b)(4). 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
[146349039]
It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified. No patient or surgical involvement. No further information available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-02253 |
| MDR Report Key | 8629426 |
| Date Received | 2019-05-21 |
| Date of Report | 2019-10-01 |
| Date Mfgr Received | 2019-09-25 |
| Device Manufacturer Date | 2015-04-28 |
| Date Added to Maude | 2019-05-21 |
| 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 | PLASMAX PLUS COUNTERBALANCE |
| Generic Name | INSTRUMENT, SPORTS MEDICINE |
| Product Code | KSS |
| Date Received | 2019-05-21 |
| Returned To Mfg | 2019-05-09 |
| Catalog Number | 800-0512 |
| Lot Number | 045033 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-21 |