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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Date 11/04/2019

Event Type  Injury  

Event Description

It was reported that the patient had partial thickness cuff tear who underwent subacromial decompression distal clavicle excision and bioinductive implant on (b)(6) 2019.Patient with persistent pain was treated with medication with mild temporary relief.A revision surgery performed on (b)(6) 2019 and showed rice bodies.Patient had history of childhood rheumatology and fibromyalgia.The actual patient condition is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: lot number information is not provided and no additional information received for documentation review.No additional information received for device labeling review.The risks associated with complaint are already included in the risk analysis.Also the probability is appropriate.Instructions for use and product labels were not reviewed due to unavailability of device information (part number, lot number).Another complaint related to inflammation due to rice bodies has been observed.Clinically relevant supporting documentation was not provided; therefore a thorough medical investigation could not be performed.The patient impact beyond the reported pain and revision procedure could not be determined.Should medical documentation become available in the future the clinical/medical task may be re-evaluated.The product used for treatment, was not returned for evaluation and therefore a physical investigation could not be completed.Root cause was undetermined after investigation.Failure mode experienced by the user facility were unable to be confirmed through direct physical investigation.The issue will be monitored for trending purposes and no further investigation warranted at this time.Investigation will be revisited if additional information is received.

• Brand Name: BIOINDUCTIVE IMPLANT
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): ROTATION MEDICAL, INC.; 15350 25th ave. no., suite 100; plymouth MN
• MDR Report Key: 9405947
• MDR Text Key: 169088806
• Report Number: 3009351468-2019-00118
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR