MAUDE Adverse Event Report: SAFE ORTHOPAEDICS STERISPINE PS; AUTO-ADJUST SCREW

Model Number AUTO-ADJUST SCREW

Device Problem Device Slipped (1584)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

The sliding rod is not directly induced by our product.The product has been manufactured in accordance with our specifications.The screw has been validated in conformance with astm f1798 and astm f1717.According to our information, the sliding rod is due to a wrong tightening of setscrews.It is due to a non-respect of surgical guide, rod bending is not sufficient in order to allow realignment of vertebrae.It is for this reason that the rod has moved.An action plan is in process in order to inform the surgeons and distributors and sensibilize our user on the tightening (refer to (b)(4)).A sensibilization to surgeon has been done by our consultant.

Event Description

On the x-ray the set screw is clearly visible having migrated from the screw and the rod appears to have moved also.

• Brand Name: STERISPINE PS
• Type of Device: AUTO-ADJUST SCREW
• Manufacturer (Section D): SAFE ORTHOPAEDICS; allée rosa luxembourg; parc des bellevues; eragny sur oise, france 95610 ; FR 95610
• Manufacturer (Section G): SAFE ORTHOPAEDICS; allée rosa luxembourg; parc des bellevues; eragny sur oise, france 95610 ; FR 95610
• Manufacturer Contact: stephanie robert ; allée rosa luxembourg; parc des bellevues; eragny sur oise, france 95610 ; FR 95610
• MDR Report Key: 8272089
• MDR Text Key: 134209283
• Report Number: 3009509485-2018-00001
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: AUTO-ADJUST SCREW
• Device Catalogue Number: PSACL640/PSACL645
• Device Lot Number: MG4572/MH4573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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