MAUDE Adverse Event Report: JOHNSON & JOHNSON; DYNJ0713177

Catalog Number	DYNJ0713177
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that during a c-spine fusion, the surgeon pulled the string and the neuro sponge detached inside the patient's neck.

• Common Device Name: DYNJ0713177
• Manufacturer (Section D): JOHNSON & JOHNSON; 1 johnson and johnson plaza; new brunswick NJ 08901
• MDR Report Key: 7700917
• Report Number: 1423395-2018-00039
• Device Sequence Number: 756944
• Product Code: OJG
• UDI-Device Identifier: 10889942085088
• UDI-Public: 10889942085088
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ0713177
• Device Lot Number: 17KK2885
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other