MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for ARTICULATING ARM LATERAL N/A 8734-0020 manufactured by Zimmer Biomet Spine.
[61098800]
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[61098801]
While operating, the articulating arm stopped tightening. There was no harm to the patient and the procedure was completed with another device.
Patient Sequence No: 1, Text Type: D, B5
[77019468]
The returned device was evaluated. The outer joints would not lock into position when the knob was tightened; the complaint is confirmed. A review of the manufacturing records did not identify any issues which would have contributed to this event. Reference report 3012447612-2017-00164.
Patient Sequence No: 1, Text Type: N, H10
[77019469]
While operating, the articulating arm stopped tightening. There was no harm to the patient and the procedure was completed with another device. This is report one of two for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004485144-2016-00334 |
| MDR Report Key | 6126445 |
| Date Received | 2016-11-23 |
| Date of Report | 2017-06-02 |
| Date of Event | 2016-10-27 |
| Date Mfgr Received | 2017-05-23 |
| Device Manufacturer Date | 2012-05-03 |
| Date Added to Maude | 2016-11-23 |
| 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 | MR. GEOFFREY GANNON |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | ZIMMER BIOMET SPINE |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTICULATING ARM LATERAL |
| Generic Name | ARTICULATING ARM |
| Product Code | LHX |
| Date Received | 2016-11-23 |
| Returned To Mfg | 2016-11-04 |
| Model Number | N/A |
| Catalog Number | 8734-0020 |
| Lot Number | L562888 |
| ID Number | N/A |
| 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 SPINE |
| Manufacturer Address | 310 INTERLOCKEN PARKWAY SUITE 120 BROOMFIELD CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-23 |