MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-27 for RHOTON HOOK ANG 90DEG SEMI-SHARP 7-1/2IN NL3785-009 manufactured by Carefusion, Inc.
[93576210]
(b)(4). If further information becomes available a follow up medwatch will be submitted. No device returned
Patient Sequence No: 1, Text Type: N, H10
[93576231]
Received a medwatch report from the customer reporting, the tip of a carefusion (b)(4) nerve hook broke off while in use. Patient is a (b)(6) year old male, patient id (b)(6). Additional information received 15nov2017: the customer reported the medwatch was filed with the fda, no report number was provided. " we only have the patient identifier, which is the same number for your medwatch report. " patient had no injury. Patient did undergo an x-ray to detect a foreign body, which was negative. Patient's medical status after the event was stable. Unknown if any part of the device broke or fell into patient's body field. Patient did have an x-ray in the or by fluoro on (b)(6) 2017 of the cervical spine which was negative for fb. Unknown how the event was resolved. The procedure was an anterior cervical diskectomy with arthrodesis, c4-5, c5-6, ulnar nerve release, which was completed as planned. The device is not available for return at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1923569-2017-00155 |
| MDR Report Key | 7060189 |
| Date Received | 2017-11-27 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-10-04 |
| Date Mfgr Received | 2017-12-20 |
| Date Added to Maude | 2017-11-27 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 5 SUNNEN DRIVE |
| Manufacturer City | ST. LOUIS MO 63143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RHOTON HOOK ANG 90DEG SEMI-SHARP 7-1/2IN |
| Generic Name | INSTRUMENT, MICROSURGICAL |
| Product Code | GZX |
| Date Received | 2017-11-27 |
| Catalog Number | NL3785-009 |
| Lot Number | I05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 5 SUNNEN DRIVE ST. LOUIS MO 63143 US 63143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-27 |