MAUDE Adverse Event Report: LIFECELL UNKNOWN CONEXA; MESH, SURGICAL

Catalog Number UNK CONEXA

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Initial reporter: corresponding author and institution.This mdr is being reported as an individual event type as serious injury due to the reported infection with medical and surgical intervention.Multiple attempts were made to contact the corresponding author for additional information, including relevant lot numbers.To date, no additional information has been obtained.The lot number associated with this event remains unknown; therefore an internal investigation could not be performed.Based on the reported information, a relationship between the event and the conexa cannot be determined.No further actions are required; a nonconformance could not be confirmed.If additional information is received, a supplemental report will be submitted.

Event Description

During a literature review, an article titled "surgical repair of large-to-massive rotator cuff tears seems to be a better option than patch augmentation or débridement and biceps tenotomy: a prospective comparative study" reported a prospective study from october 2012 to july 2016 of 32 consecutive patients to compare the outcomes after 3 different treatments for large and massive rotator cuff tears.Eleven patients (5 male, 6 female, mean age 56 years) in the patch group received conexa.Patients were evaluated before and after the operation at 3, 6, 12 and 24 months.This mdr is associated with the conexa complications only.In the patch group, 1 deep infection required the removal of the patch and antibiotic treatment.It was confirmed that this complication was not previously reported as a complaint to lifecell at the time of the event.

• Brand Name: UNKNOWN CONEXA
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471100
• MDR Report Key: 7991534
• MDR Text Key: 124592942
• Report Number: 1000306051-2018-00130
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CONEXA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR