MAUDE Adverse Event Report: ROTATION MEDICAL BIOINDUCTIVE IMPLANT - MEDIUM; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number 2169-2

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

Patient Problems Purulent Discharge (1812); Erythema (1840); Swelling (2091)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

Date of event provided ((b)(6) 2018) is approximate as an exact date was not provided for the "aspiartion" procedure (6-7 weeks post-operatively).Investigation narrative: a review of the device history records for this device confirmed the lot to be sterile.Additional information has been requested from the complainant regarding this incident and the investigation is ongoing.

Event Description

It was reported that 6-7 weeks after shoulder surgery performed on (b)(6) 2018 using a regeneten patch, the patient went to physical therapy and the therapist noted the shoulder was very red and swollen.The physician aspirated a large amount of pus from the patients shoulder.Subsequently on (b)(6) 2018, an incision and drainage wash out that included removal of the patch and remaining suture material was performed due to suspected infection and/or implant rejection.It was stated that the previously implanted s&n suture anchors remained in the patient and test results were negative for infection.Current patient status is unknown, however, no further complications have been reported.Report 1 of 2 to capture medical intervention (aspiration) that occurred 6-7 weeks post-operatively.See related report 3009351468-2019-00002 for 2nd event (i&d wash out/removal procedure) that occurred on (b)(6) 2018.

• Brand Name: BIOINDUCTIVE IMPLANT - MEDIUM
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): ROTATION MEDICAL; 15350 25th avenue north; suite 100; plymouth MN 55447
• Manufacturer (Section G): ROTATION MEDICAL; 15350 25th avenue north; suite 100; plymouth MN 55447
• Manufacturer Contact: garrett ahlborg ; 15350 25th avenue north; suite 100; plymouth, MN 55447 ; 7637467531
• MDR Report Key: 8285867
• MDR Text Key: 134374041
• Report Number: 3009351468-2019-00001
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 2169-2
• Device Lot Number: RC2AN18K4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention