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 Dislodged or Dislocated (2923)

Patient Problem Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: returned plate examined under magnification.Plate has no signs of damage to any locking threads, and remainder of plate is in good condition.Additional mdrs associated with this event: 3025141-2019-00201: screw 1, 3025141-2019-00202: screw 2, 3025141-2019-00203: screw 3, 3025141-2019-00204: screw 4, 3025141-2019-00205: screw 5, 3025141-2019-00206: screw 6, 3025141-2019-00207: screw 7.

Event Description

A acu-loc 2 vdr plate was implanted in the patient on (b)(6) 2018.At some point post op, a screw broke and a screw backed out, rupturing the patient's tendon.The hardware was removed on (b)(6) 2019.

• 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 ; 8886279957
• MDR Report Key: 8499099
• MDR Text Key: 141447626
• Report Number: 3025141-2019-00200
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70-0356
• Device Catalogue Number: 70-0356
• Device Lot Number: 379037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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