MAUDE Adverse Event Report: ACUMED, LLC; PLATE, FIXATION, BONE

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

Patient Problem Joint Contracture (4528)

Event Type  Injury  

Manufacturer Narrative

Manufacturing and inspection records could not be reviewed as device information is unknown.Based on the information available, the root cause could not be determined.Related reports: 3025141-2023-00078, 3025141-2023-00079, 3025141-2023-00080, 3025141-2023-00081, 3025141-2023-00082, 3025141-2023-00083, 3025141-2023-00084, 3025141-2023-00085, 3025141-2023-00087, 3025141-2023-00088, 3025141-2023-00089, 3025141-2023-00090, 3025141-2023-00091, 3025141-2023-00092, 3025141-2023-00093, 3025141-2023-00094, 3025141-2023-00095, 3025141-2023-00096, 3025141-2023-00097, 3025141-2023-00098, and 3025141-2023-00099.

Event Description

In the article "mini-fragment plating of olecranon fractures is comparable to precontoured small-fragment plating" by wadhwa et al, patients were stratified into two cohorts based on fixation construct: 1) treatment with mini-fragment fixation (2.7mm implants or less from competitor manufacturer) and 2) treatment with a precontoured olecranon-specific plate (acumed brand product as well as precountoured olecranon-specific plates from competitor manufacturers).In the precontoured cohort, there was one case of ulnar neuritis that did not undergo decompression, one case of urinary retention, one case of suture abscess, and one case of heterotopic ossification that did not undergo reoperation.Reoperations were as follows: one case of ulnar nerve entrapment that underwent decompression, one nonunion revision, one revision for peri-implant fracture and subsequent infection, one revision for hypertrophic scar, and one reoperation for posttraumatic contracture.Additionally, there were three cases of deep infection, one of which resulted in fixation failure.There were two additional cases of fixation failure.Four additional patients experienced heterotopic ossification that underwent revision, one of which had concomitant post-traumatic contracture.There were four cases of wound dehiscence.One wound dehiscence was associated with a seroma formation and arthrofibrosis, another with skin necrosis, and another with osteomyelitis, infected implants, septic arthritis, and elbow contracture with heterotopic ossification.All cases went on to eventual union.It is unknown how many of these patient had the acumed plates implanted versus the plates from the competitor manufacturer.Report 9 of 22.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5036279957
• MDR Report Key: 16614772
• MDR Text Key: 312008908
• Report Number: 3025141-2023-00086
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2023
• 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): Other