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
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Weight Changes (2607)
Date of Event	06/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2027467-2021-00058
• Device Sequence Number: 3671418
• Product Code: KWP
• UDI-Device Identifier: 00844856003026
• UDI-Public: 00844856003026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female