MAUDE Adverse Event Report: ALPHATEC SPINE, INC ZODIAC TI STANDARD POLYAXIAL SCREW ASSY, 6.5MM X 45MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 62065-45

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Unspecified Infection (1930); Pain (1994); Weight Changes (2607)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.

Event Description

On (b)(6) 2021, a female patient underwent a revision surgery due to loosening of the l3 screw.It was reported this was a result of weight reduction caused by collagen disease, pain, and (b)(6).While removing the screw the surgeon could not unlock the screw head.He was able to remove the screw in the lock position due to the loosening.

Manufacturer Narrative

Corrected data: h6: medical device problem code: 2993.Component code: 568.Type of investigation: 10; 3331.Investigation findings: 213.Investigation conclusion: 67.Device evaluation: h10: visual inspection indicated the tulip head was initially locked; therefore, confirming the reported event.This is expected as the zodiac screws are designed to have a provisional lock in the screw head.When the screw is final tightened (or provisionally) the bushing component wedges between the shank sphere and the tulip side wall creating a locked joint.When the rod is removed the joint remains locked due to the wedging action.No product problem was found to exist.The polyaxial screws are intended to have the screw body lock into a fixed position once the bushing has been compressed.

• Brand Name: ZODIAC TI STANDARD POLYAXIAL SCREW ASSY, 6.5MM X 45MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: jayson alaba ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946771
• MDR Report Key: 12304930
• MDR Text Key: 265971435
• Report Number: 2027467-2021-00058
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00844856003026
• UDI-Public: 00844856003026
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100685
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 62065-45
• Device Catalogue Number: 62065-45
• Device Lot Number: 622846
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female