MAUDE Adverse Event Report: ACUMED LLC; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this article: 3025141-2020-00303: case 1, 3025141-2020-00304: case 2, 3025141-2020-00305: case 3, 3025141-2020-00306: case 4, 3025141-2020-00307: case 5, 3025141-2020-00308: case 6, 3025141-2020-00309: case 7, 3025141-2020-00310: case 8, 3025141-2020-00311: case 9, 3025141-2020-00312: case 10, 3025141-2020-00313: case 11, 3025141-2020-00314: case 12, 3025141-2020-00315: case 13, 3025141-2020-00316: case 14, 3025141-2020-00317: case 15, 3025141-2020-00318: case 16, 3025141-2020-00319: case 17, 3025141-2020-00320: case 18, 3025141-2020-00321: case 19, 3025141-2020-00322: case 20, 3025141-2020-00323: case 21, 3025141-2020-00324: case 22, 3025141-2020-00325: case 23, 3025141-2020-00326: case 24, 3025141-2020-00327: case 25, 3025141-2020-00328: case 26, 3025141-2020-00329: case 27, 3025141-2020-00330: case 28, 3025141-2020-00331: case 29, 3025141-2020-00332: case 30, 3025141-2020-00333: case 31, 3025141-2020-00335: case 33, 3025141-2020-00336: case 34, 3025141-2020-00337: case 35, 3025141-2020-00338: case 36, 3025141-2020-00339: case 37, 3025141-2020-00340: case 38, 3025141-2020-00341: case 39, 3025141-2020-00342: case 40, 3025141-2020-00343: case 41, 3025141-2020-00344: case 42, 3025141-2020-00345: case 43, 3025141-2020-00346: case 44.

Event Description

Article: optimizing long-term outcomes and avoiding failure with the fibula intramedullary nail; carter, thomas h.; mackenzie, samuel p.; bell, katrina r., macdonald, deborah; and white, timothy o.J orthop trauma · volume 33, number 4, april 2019.Case 32: patient experienced noninfected symptomatic implants post op following implantation of a fibula nail.The distal locking screws were removed in a revision surgery.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 10999242
• MDR Text Key: 221241746
• Report Number: 3025141-2020-00334
• Device Sequence Number: 1
• Product Code: HSB
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• 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: 11/20/2020
• 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