MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for 4.0MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM RODS 04.615.126 manufactured by Wrights Lane Synthes Usa Products Llc.
[185790204]
Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[185790205]
It was reported on an unknown date that during the postoperative visit , there was a broken titanium cancellous polyaxial screw found at the thoracic 1 level post posterior cervical fusion procedure. The patient had surgery six months ago. The procedure outcome is unknown. There were no patient consequences. Concomitant devices reported: unk - lamina/pedicle/process hooks: synapse (part# unknown, lot# unknown, quantity unknown). Unk - mono/polyaxial screw collars/sleeves/heads: synapse (part# unknown, lot# unknown, quantity unknown). Unk - mono/polyaxial screws: synapse (part# unknown, lot# unknown, quantity unknown). Unk - rods: synapse (part# unknown, lot# unknown, quantity unknown). This complaint involves 1 device. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01616 |
| MDR Report Key | 9901184 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-30 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.0MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM RODS |
| Generic Name | ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION |
| Product Code | NKG |
| Date Received | 2020-03-30 |
| Model Number | 04.615.126 |
| Catalog Number | 04.615.126 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |