MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC SHIELDLOC 7.5MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number N/A

Device Problem Migration (4003)

Patient Problem Irritation (1941)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item number: 10-1008-1075, armorlink 7.5mm, lot number: f132729.Customer has indicated that the product will not be returned to orthopediatrics for investigation as it was disposed of at the facility.Multiple mdr reports were filed for this event, please see associated reports: 3006460162-2019-00068.

Event Description

It has been reported that following an acl correction, the patient underwent a revision due to migration of the screw.No additional patient consequences were reported.

Manufacturer Narrative

The follow is being submitted to relay additional information.Updated: h4 updated 26 jul 2013.H6 updated method 3331, 4114, 4115 and 4109.H6 updated results 3207.H6 updated conclusion 4315.Complaint sample was not returned for evaluation.Reported event was not confirmed.Dhr was reviewed.No deviations or rework was reported.Risk management file review was deemed appropriate.Review of the complaint history determined that no further action is required as there were no trends identified.Root cause was unable to be determined.

• Brand Name: SHIELDLOC 7.5MM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 9395187
• MDR Text Key: 168645840
• Report Number: 3006460162-2019-00067
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K130217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10-1008-4075
• Device Lot Number: F13729
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 68