MAUDE Adverse Event Report: ALPHATEC SPINE INC SET SCREW (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number	47127
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The implants have not been removed from the patient nor has the identifying lot number been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
Post op x-rays taken (b)(6) 2019 revealed two set screws had loosened and dislodged from both polyaxial screws.The arsenal construct was implanted on (b)(6) 2019 during a revision surgery for the same type of occurrence (ref.Mdr 2027467-2019-00022).
Additional Manufacturer Narrative
The returned implants are currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
The set screw bottom surface is the surface that interacts with the rod to create a stable construct, therefore the wear pattern on these surface were inspected.The expected contact surface between set screw and rod after fully tightened results in two inline marks on the set screw (2 of 4 explant set screws).1 of 4 explant set screws displayed a "starburst" wear pattern on the bottom surface of the set screw which is indicative of motion between rod and screw.1 of 4 explant set screws displayed a random wear pattern, with some "starburst" wear pattern except isolated to a single side.The tulip and set screw had no significant wear or shear/deformation of the threads.The tulip internal geometry did not display any significant wear.Investigation of the rods shows translation/slip of the mating set screw at one of the extreme ends (on both rods).Therefore, the set screw disengagement may be attributed to repeated motion at the rod-screw interface resulting in set screw back out and resulting in translation/slip along the rod.

• Brand Name: SET SCREW (TI-6AL-4V ELI)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8864367
• Report Number: 2027467-2019-00040
• Device Sequence Number: 1746843
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2019

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
• Operator of Device: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 8217901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 07/09/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/05/2019; 09/11/2019
• 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: Hospitalization; Other
• Patient Age: 67 YR