MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-18 for DYNJ0713177 manufactured by Johnson & Johnson.
[114407230]
It was reported that during a c-spine fusion, the surgeon pulled the string and the neuro sponge (taken from custom surgical kit) detached inside the patient's neck. Reportedly, the surgeon does not believe that the sponge was left in the patient; however, there is "no proof that this can be 100% clarified. " it was not reported whether test/s were done to determine if neuro sponge was actually left inside the patient. There was no follow up care or medical intervention reported related to the event. There was no reported impact to the patient or the procedure being performed. The patient is reportedly doing well at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details. Due to the reported incident and in an abundance of caution, this medwatch is being filed. The sample is not available to be returned for evaluation. A third party notification has been completed with the manufacturer of the neuro sponge involved with this event. No additional information is available. If additional information becomes available, this report will be reopened and reevaluated.
Patient Sequence No: 1, Text Type: N, H10
[114407231]
It was reported that during a c-spine fusion, the surgeon pulled the string and the neuro sponge detached inside the patient's neck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00039 |
| MDR Report Key | 7700917 |
| Date Received | 2018-07-18 |
| Date of Report | 2018-07-18 |
| Date of Event | 2018-06-12 |
| Date Mfgr Received | 2018-06-27 |
| Date Added to Maude | 2018-07-18 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | DYNJ0713177 |
| Product Code | OJG |
| Date Received | 2018-07-18 |
| Catalog Number | DYNJ0713177 |
| Lot Number | 17KK2885 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON |
| Manufacturer Address | 1 JOHNSON AND JOHNSON PLAZA NEW BRUNSWICK NJ 08901 US 08901 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-18 |