MAUDE Adverse Event Report: SCIENT'X POLYAXIAL HEMISPHERICAL SCREW 6.2MM X 40MM, TI; MNI, KWP, MNH

Model Number 12VDP62-40

Device Problems Break (1069); Fracture (1260)

Patient Problems Nausea (1970); Pain (1994); Weakness (2145)

Event Date 06/23/2014

Event Type  Injury  

Event Description

Revision surgery occurred on (b)(6) 2014 to remove the fractured hemi screw located in the right side of the patient's sacrum (s1).During the removal of the entire hemi construct, the screw located in the left side of the s1 was also found to be fractured and broke.The distal threaded shaft of only that screw could not be removed.It was reported to have been anchored too deep within the pedicle.The remainder of the construct was removed and replaced without issue.

Manufacturer Narrative

No evaluation possible.The explanted construct will not be returned to alphatec.Additional information provided by the sales rep "the surgeon mentioned that the patient was hyperlordosed which may have created shearing on the screws".

Event Description

A patient leaned over to throw trash away on (b)(6) 2014 and felt a "grinding" in her lower back & abdomen.The pain made the patient feel sick to her stomach and weak in the knees as she felt the "grinding".She met with the surgeon on (b)(6) 2014 at which time x-rays confirmed the hemi screw located at the s1 had fractured and broke.The fracture appears to be located just past the head of the screw at the minor diameter of the most proximal thread.The hemispherical polyaxial screw was originally implanted on (b)(6) 2014.Revision surgery has not yet been decided.

Manufacturer Narrative

The implant in question was produced by a foreign manufacturer which is wholly owned by (b)(4).An evaluation of the suspect device cannot be performed.The hemispherical screw has not been explanted and remains securely anchored within the patient's s1 sacrum.Upon the receipt of additional information and/or removal of the implant, a follow up report will be submitted.

• Brand Name: POLYAXIAL HEMISPHERICAL SCREW 6.2MM X 40MM, TI
• Type of Device: MNI, KWP, MNH
• Manufacturer (Section D): SCIENT'X; 18 rue robespierre; beaurains, 6221 7; FR 62217
• Manufacturer Contact: david mcgrath ; 5818 el camino real; carlsbad, CA 92008 ; 7604946936
• MDR Report Key: 3754020
• MDR Text Key: 16778899
• Report Number: 2027467-2014-00006
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 12VDP62-40
• Device Catalogue Number: 12VDP62-40
• Device Lot Number: 1YBB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2013
• 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): Other; Required Intervention
• Patient Age: 30 YR