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 Adhesion(s) (1695); Capsular Contracture (1761)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested from the complainant regarding this incident and the investigation is currently ongoing.

Event Description

It was reported that the patient underwent initial surgery with the bioinductive implant on (b)(6) 2017, and is now presenting with contractive/adhesive capsulitis.The clinical site has deemed this condition "possibly related" to the bioinductive implant.The patient was treated with two shoulder injections (b)(6) 2018 and (b)(6) 2018).Symptoms persisted and the patient is awaiting surgery for capsular release, manipulation under anesthesia, decompression, and debridement.No further information has been provided.

• 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: 8533560
• MDR Text Key: 142607562
• Report Number: 3009351468-2019-00004
• 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: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2169-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2019
• 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