MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC ORTHOPEDIATRICS RESPONSE LARGE SET SCREW; PEDICLE SCREW SPINAL SYSTEM

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 10/05/2018

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).Customer has indicated that the product will not be returned to orthopediatrics for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that following the placement of a response spine construct, two set screws were discovered to be disengaged.The patient was successfully revised.No additional patient consequences were reported.

• Brand Name: ORTHOPEDIATRICS RESPONSE LARGE SET SCREW
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, IN 46582 ; 5742670872
• MDR Report Key: 8048365
• MDR Text Key: 126452528
• Report Number: 3006460162-2018-00071
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 0084113210010
• UDI-Public: (01)0084113210010(10)M86486-B
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K150600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• 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: 00-1003-4001
• Device Lot Number: M86486-B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 14 YR
• Patient Weight: 55