MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-21 for COBB SPINAL ELEVATOR-HEAVY DUTY 1/2 INCH WIDTH N/A 00289400200 manufactured by Zimmer, Inc..
[73670232]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[73670233]
It is reported that the device tip detached from the handle during surgery. The surgeon finished the surgery with an alternative device. No serious injury has been reported for this event.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 0001822565-2017-02700 |
MDR Report Key | 6513433 |
Date Received | 2017-04-21 |
Date of Report | 2017-07-08 |
Date of Event | 2017-03-10 |
Date Mfgr Received | 2017-07-06 |
Device Manufacturer Date | 2014-10-21 |
Date Added to Maude | 2017-04-21 |
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, INC. |
Manufacturer Street | 1800 WEST CENTER STREET |
Manufacturer City | WARSAW IN 46580 |
Manufacturer Country | US |
Manufacturer Postal Code | 46580 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | N/A |
Event Type | 3 |
Type of Report | 0 |
Brand Name | COBB SPINAL ELEVATOR-HEAVY DUTY 1/2 INCH WIDTH |
Generic Name | ELEVATOR, SURGICAL |
Product Code | GEG |
Date Received | 2017-04-21 |
Returned To Mfg | 2017-06-02 |
Model Number | N/A |
Catalog Number | 00289400200 |
Lot Number | 62850826 |
ID Number | N/A |
Operator | PHYSICIAN |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ZIMMER, INC. |
Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-04-21 |