MAUDE Adverse Event Report: ALPHATEC SPINE INC OSSEOSCREW SPINAL FIXATION SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	53065-45
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned implant is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
The tulip/head of the screw fractured and broke during final tightening.
Additional Manufacturer Narrative
Review of the device history records revealed the implant was properly manufactured and released in accordance with design specifications.No irregularities have been identified.The evaluation determine that while considering the picture and description of events provided by the rep/surgeon, the implant/instruments returned for evaluation, as well as analysis of the devices, it appears that the tulip failure was caused by driving a cross-threaded set screw into the tulip/head.

• Brand Name: OSSEOSCREW SPINAL FIXATION SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 9489680
• Report Number: 2027467-2019-00060
• Device Sequence Number: 16992400
• Product Code: NKB
• UDI-Device Identifier: 00844856049130
• UDI-Public: (01)00844856049130(10)715919
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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: 53065-45
• Device Catalogue Number: 53065-45
• Device Lot Number: 715919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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