MAUDE Adverse Event Report: ACUMED LLC 3.5MM X 14.0MM LOCKING CORTICAL SCREW; SCREW, FIXATION, BONE

Model Number COL-3140-S

Device Problem Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2019-00367 follow up 1: screw 1.3025141-2019-00376: plate.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.

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: 3.5MM X 14.0MM LOCKING CORTICAL SCREW
• Type of Device: SCREW, 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: 9077660
• MDR Text Key: 160558330
• Report Number: 3025141-2019-00383
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120903
• 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

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COL-3140-S
• Device Catalogue Number: COL-3140-S
• Device Lot Number: 447229
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2018
• 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