MAUDE Adverse Event Report: ACUMED LLC 3.5MM X 12.0MM LOCKING CORTICAL SCREW; SCREW, FIXATION, BONE

Model Number COL-3120-S

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

The patient, who have been implanted with two aculoc 2 plates and was non-union, fell down and the plate broke.The plates and screws were explanted.

Manufacturer Narrative

Additional mdr's associated with this event: 3025141-2015-00108: plate 1, 3025141-2015-00109: plate 2, 3025141-2015-00110: screw 1, 3025141-2015-00111: screw 2, 3025141-2015-00112: screw 3, 3025141-2015-00113: screw 4, 3025141-2015-00114: screw 5, 3025141-2015-00115: screw 6, 3025141-2015-00117: screw 8, 3025141-2015-00118: screw 9, 3025141-2015-00119: screw 10.

• Brand Name: 3.5MM X 12.0MM LOCKING CORTICAL SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 943
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 943
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432 ; 5036279957
• MDR Report Key: 4939794
• MDR Text Key: 6256719
• Report Number: 3025141-2015-00116
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2015

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: Physician
• Device Expiration Date: 05/31/2021
• Device Model Number: COL-3120-S
• Device Catalogue Number: COL-3120-S
• Device Lot Number: 328716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2014
• 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: 61 YR