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

Model Number 70-0358-S

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2019-00367 follow up 1: screw 1; 3025141-2019-00377: screw 2; 3025141-2019-00378: screw 3; 3025141-2019-00379: screw 4; 3025141-2019-00380: screw 5; 3025141-2019-00381: screw 6; 3025141-2019-00382: screw 7; 3025141-2019-00383: screw 8.

Event Description

Eight cortical screws and a aculoc vdr plate were implanted on (b)(6) 2019.During a post op visit, x-rays were taken and an unidentified object was seen.The screws and plate were removed on (b)(6) 2019 but all of the object could not be removed.Almost all of the thread on the screw was sheared off.

• Brand Name: ACU-LOC® 2 VDR PLT, NARROW, 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: 9077640
• MDR Text Key: 162518084
• Report Number: 3025141-2019-00376
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/20/2019

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
• Device Model Number: 70-0358-S
• Device Catalogue Number: 70-0358-S
• Device Lot Number: 443881
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2018
• 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
• Patient Age: 52 YR