MAUDE Adverse Event Report: ORTHOPEDIATRICS CORP. RESPONSE 5.5/6.0 SPINE SYSTEM; PEDICLE SCREW SPINAL SYSTEM, PRODUCT CODE:OSH

Catalog Number 00-1003-4001

Device Problem Detachment Of Device Component (1104)

Patient Problem Congenital Defect/Deformity (1782)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

Set screw disassociated from polyaxial screw causing rod to disengage from polyaxial screw.Surgeon discovered at 6-week follow-up visit with patient.Surgeon stated he was certain that the dissociation occurred due to the rod not being fully seated, and the driver not being able to overcome the force of the 6.0mm cocr rod.Surgeon further stated that when he performed the revision surgery on the patient, he observed that the rod was not fully seated.Upon utilizing the reduction tower intended to assure the rod is fully seated into the pedicle screw, he observed that the rod did reduce further.He then final tightened the set screw using the toque limiting driver handle.Reduction tower instruments are provided to specifically provide additional mechanical advantage to aid surgeon in seating the rod into the bottom of the pedicle screw prior to final tightening of set screw.Surgical technique shows how to visually or via palpitation confirm that set screw is fully seated.Device not returned for evaluation.

Event Description

During a post-op follow-up visit, it was noted on x-ray that one of the 6.0 cocr rods had dissociated from the pedicle screw.A revision surgery was performed that same day.

Manufacturer Narrative

(b)(4).Recall number: 3006460162-04-11-2017-001-c.

• Brand Name: RESPONSE 5.5/6.0 SPINE SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, PRODUCT CODE:OSH
• Manufacturer (Section D): ORTHOPEDIATRICS CORP.; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: mark fox ; 2850 frontier drive; warsaw, IN 46582 ; 5742686379
• MDR Report Key: 5934477
• MDR Text Key: 54140287
• Report Number: 3006460162-2016-00003
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-1003-4001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 68