MAUDE Adverse Event Report: ALPHATEC SPINE INC POLYAXIAL SCREW, 9.5 MM X 80 MM (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number	47000-095-080
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records found no manufacturing, processing or design related irregularities.The polyaxial screw was found to be properly manufactured and released in accordance with the device master record.Visual inspection of the returned implant found that the screw remained completely intact.However, the internal bushing is misaligned/deformed and disengaged from the tulip/head and bone screw.Under magnification multiple score marks and galling likely caused during surgeons struggle to unlock the bushing were clearly visible.The excessive damage will no longer allow a rod or set screw to be secured within the tulip/head causing the implant to be unusable.The evidence suggests the surgeon accidently broke the screw while attempting removal following improper placement.
Event or Problem Description
Surgeon buried the screw and the tulip popped up.She tried to back it up and could not get it angled.The surgeon used a mallet, then levered on the tulip and the clip disengaged.Surgery was successful despite the malfunction.The event cause over a 30 minute delay in the case.

• Brand Name: POLYAXIAL SCREW, 9.5 MM X 80 MM (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: 8487626
• Report Number: 2027467-2019-00013
• Device Sequence Number: 2384120
• Product Code: NKB
• UDI-Device Identifier: 00844856071469
• UDI-Public: (01)00844856071469(10)7556720
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K133221
• 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
• Report Date (Section B): 03/06/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 47000-095-080
• Device Catalogue Number: 47000-095-080
• Device Lot Number: 7556720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/05/2019
• 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