MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC RESPONSE SPINE 5.5, SET SCREW, SMALL; PEDICLE SCREW SPINAL SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant product: item: 00-1300-5028, fixed cross connector, 28mm, lot: unknown.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.

Event Description

It was reported that during the placement of a response spinal construct, a small set screw sheered off and was left in the patient.No adverse events have been reported as a result of the malfunction.

• Brand Name: RESPONSE SPINE 5.5, SET SCREW, SMALL
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, in ; 2670872
• MDR Report Key: 9742964
• MDR Text Key: 190697644
• Report Number: 3006460162-2019-00041
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160466
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-1003-3012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability