MAUDE Adverse Event Report: ACUMED LLC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL

Device Problems Material Protrusion/Extrusion (2979); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional cases associated with this article: 3025141-2019-00404: case 1, 3025141-2019-00405: case 2, 3025141-2019-00406: case 3, 3025141-2019-00408: case 5, 3025141-2019-00409: case 6, 3025141-2019-00410: case 7.

Event Description

Article: the results of internal fixation of three- and four-part proximal humeral fractures with the polarus nail, adedapo, a.O., ikpeme, j.O.; injury: international journal of the care of the injured 32 (2001) 115-121.Case 4: a polarus nail was implanted.Patient experienced proximal screw loosening and extrusion that caused pain; the screws were removed in a revision surgery.

• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL
• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 9241771
• MDR Text Key: 164236181
• Report Number: 3025141-2019-00407
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/25/2019
• 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): Required Intervention