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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for evaluation and further information regarding the event could not be obtained.Manufacturing and inspection records could not be reviewed as device information (model number, batch/lot number) is unknown.

Event Description

An email was received via the acumed public website from an allergist in (b)(6) who was requesting the metal composition of acutrak mini screw in order "to study a possible case of contact dermatitis post-iq".No further information was provided regarding the model number or batch/lot number of the acutrak mini screw in question.Additionally, no further information was provided regarding the initial implant procedure using the acutrak mini screw (where the screws were implanted, when the implant occurred, etc.).An email was sent to the allergist providing the metal composition of the screws.Follow up has also been conducted requesting more information, but a response has not been received.

• Type of Device: SCREW, 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 ; 5035209618
• MDR Report Key: 14242939
• MDR Text Key: 290543104
• Report Number: 3025141-2022-00116
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K944330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other