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

Catalog Number UNKNOWN

Device Problems Material Fragmentation (1261); Noise, Audible (3273)

Patient Problems Inflammation (1932); Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient had bursal sided partial thickness tear.The surgeon did not do a primary repair with the anchors, he used regeneten.Three months after the surgery the patient exhibited a lot of pain and heard a popping sound.An mri was performed and it showed a lot of fragments and was ¿lit up¿.The surgeon decided to wait a couple of months thinking that the issue reported by the patient it was inflammatory and healing.Patient reported several condition related to swelling the doctor did pull some samples for biopsy, awaiting results, 2 surgeries were performed.

Manufacturer Narrative

H3,h6: the products were not returned for evaluation and therefore a physical investigation could not be completed.Although the issues experienced by the user facility were unable to be confirmed through direct physical investigation.Device information was not provided.

• Brand Name: TBD
• 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: 8645296
• MDR Text Key: 146211445
• Report Number: 3009351468-2019-00100
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other