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 2018-01-02 for BONE SCR 6.5X30 SELF-TAP N/A 00625006530 manufactured by Zimmer Biomet, Inc..
[96178234]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Discarded.
Patient Sequence No: 1, Text Type: N, H10
[96178235]
It was reported that during a left revision hip procedure the screw fractured, and a piece was left in the patient. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
[132595893]
Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number. This event will be reported on 0002648920 - 2018 - 00552.
Patient Sequence No: 1, Text Type: N, H10
[132595894]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-08650 |
| MDR Report Key | 7158225 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-01-02 |
| Date of Report | 2018-08-03 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 2017-10-02 |
| Date Added to Maude | 2018-01-02 |
| 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 | BONE SCR 6.5X30 SELF-TAP |
| Generic Name | SCREW, FIXATION |
| Product Code | NLF |
| Date Received | 2018-01-02 |
| Model Number | N/A |
| Catalog Number | 00625006530 |
| Lot Number | 63794447 |
| ID Number | (01) 00889024119826 (17) 27093 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2018-01-02 |