MAUDE Adverse Event Report: ALPHATEC SPINE INC ZODIAC LUMBAR SPINAL FIXATION SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	62055-45
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records found no manufacturing, processing or design related irregularities.The implants were found to be properly manufactured and released in accordance with the device master record.An evaluation is not possible at this time.The fractured screws have not yet been removed from the patient.
Event or Problem Description
One year and 4 months after the initial surgery, post-op x-rays found that both l5 screws (right/left) had fractured & broke.The patient is reported to have lower limbs numbness and low back pain.Revision surgery schedule for early (b)(6).(b)(6) 2019: initial surgery was conducted.Plif (zodiac degenerative fixation system and another manufacturer's spacer).

• Brand Name: ZODIAC LUMBAR SPINAL FIXATION SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 10861726
• Report Number: 2027467-2020-00048
• Device Sequence Number: 11096667
• Product Code: KWP
• UDI-Device Identifier: 00844856002944
• UDI-Public: (01)00844856002944(10)712338
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 62055-45
• Device Catalogue Number: 62055-45
• Device Lot Number: 712338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR