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

Model Number UNKNOWN

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The surgeon attempted to remove the locking bolt, and the bolt broke.A portion of the locking bolt remains in the patient and could not be retrieved.The screw could not be inserted in that hole because the broken fragment could not be removed.Device information for the acu-loc 2 plate involved in this event is unknown.This report is related to report number 3025141-2022-00078 which is for the locking bolt involved in this event.This report is for the plate.

• Brand Name: UNKNOWN PLATE
• 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 ; 5035209618
• MDR Report Key: 14047836
• MDR Text Key: 294666193
• Report Number: 3025141-2022-00079
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2022
• 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 Race: Asian