MAUDE Adverse Event Report: ALPHATEC SPINE, INC. REDUCTION SCREW EXTENDER (STAINLESS STEEL); LXH

Model Number	73772
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The additional screw extenders reported to have an issue detaching are of the same product part number/description but contain a separate identifying lot number.Lot# mc4128005 manufactured 7/6/2017.Visual inspection revealed that one of the locking tabs of each of the three instruments has been completely removed/detached.It appears this was done by the surgeon in order to release the instruments from the mating polyaxial screw as specified by the sales rep.This would indicate that the alignment guide may have not been utilized during attachment of the polyaxial screw and extender.Illico surgical technique guide (lit-83323) provides direction as to loading and unloading to ensure proper performance of the device.It is mandatory to use the screw alignment guide to attach screw extenders to screws.Failure to do so may result in unpredictable surgical complications.Additionally, the release point of the screw extenders is 90° (continued rotation will not release the product).Insert screw extender remover into screw extender with handle parallel to the implant rod.Rotate 90° clockwise.Gently pull the t-handle up to release screw extender.Note: if the screw extender does not disengage, do not use force.Use screw remover aid.
Event or Problem Description
During an mis case, the surgeon encounter difficulty removing 3 of 8 screw extenders from the mating polyaxial screws.He was able to detach them by removing part of the instrument.The event caused approximately a 40 minute delay in the case.

• Brand Name: REDUCTION SCREW EXTENDER (STAINLESS STEEL)
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 7600742
• Report Number: 2027467-2018-00036
• Device Sequence Number: 13798895
• Product Code: LXH
• UDI-Device Identifier: 00840967192901
• UDI-Public: (01)00840967192901(10)6799702
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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: Physician
• Device Model Number: 73772
• Device Catalogue Number: 73772
• Device Lot Number: 6799702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/14/2018
• 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: 56 YR