MAUDE Adverse Event Report: DEPUY MITEK LLC US GII QA+ O/C CP-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222983

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot number is not currently available.

Event Description

A doctor addressed concerning a patient with severe reactions from g2 anchor.The patient has got 2 anchors implanted, earlier history of severe nickel allergy is confirmed.Therefore the patient/ doctor suspects the reaction to be caused by the g2 anchors.Doctor describes the problems as aggressive reaction and the patient frequently returns to the acute care with severe astma reactions and allergic shock etc.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was implanted therefore the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.Moreover, according to the ifu," adverse effects of absorb able implanted devices include mild inflammatory and foreign body reactions".Furthermore, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).The lot number is not currently available.

Event Description

A doctor addressed concerning a patient with severe reactions from g2 anchor.The patient has got 2 anchors implanted, earlier history of severe nickel allergy is confirmed.Therefor the patient/ doctor suspects the reaction to be caused by the g2 anchors? doctor describes the problems as aggressive reaction and the patient frequently returns to the acute care with severe astma reactions and allergic shock etc.Patient consequence was unknown.Additional information received on 10/9/2018.No lot numbers are known for both the gii quickanchor orthocord.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7235727
• MDR Text Key: 98837060
• Report Number: 1221934-2018-50127
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K051989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 222983
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 10/09/2018
• Supplement Dates FDA Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other