MAUDE Adverse Event Report: CORIN MEDICAL REVIVAL; PROXIMAL BODY TRIAL

Model Number 12-0540420

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.Additional information and the return of the reported device has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be requested and reviewed.

Event Description

Revival proximal body trial would not disengage correctly from the distal component.Excessive force was required to remove the trial.

Manufacturer Narrative

(b)(6) final report.Functional testings were performed which did not reveal any anomaly: no excessive force was necessary to remove the device.The origin of the complaint may be related to a misuse.Based on this, corin now considers this case closed.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

Revival proximal body trial would not dissengage correctly from the distal component.Excessive force was required to remove the trial.

• Brand Name: REVIVAL
• Type of Device: PROXIMAL BODY TRIAL
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 10179888
• MDR Text Key: 196964332
• Report Number: 9614209-2019-00055
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K152903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12-0540420
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: J-AB0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1