MAUDE Adverse Event Report: ACUMED LLC ACU-LOC® 2 VDR PLT STD L; PLATE, FIXATION, BONE

Model Number 70-0356

Device Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00061: driver, 3025141-2020-00063: screw.

Event Description

While inserting a screw into a orthopedic plate, the driver broke off the screw head and could not be removed.It remains implanted.

• Brand Name: ACU-LOC® 2 VDR PLT STD L
• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 9899352
• MDR Text Key: 186746124
• Report Number: 3025141-2020-00062
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0356
• Device Catalogue Number: 70-0356
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2020
• 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