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

Model Number 70-0372

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2019-00344: screw.

Event Description

While implanting an aculoc 2 plate, a locking screw stripped and was spinning in the plate.It could not be removed and was left implanted.There was a 15 minute delay in surgery as a result.

• Brand Name: ACU-LOC® 2 VDR PROX PLT, STD LONG, 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 ; 8886279957
• MDR Report Key: 8883610
• MDR Text Key: 154015123
• Report Number: 3025141-2019-00345
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0372
• Device Catalogue Number: 70-0372
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• 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 Age: 62 DA