MAUDE Adverse Event Report: ALPHATEC SPINE INC VARIABLE BRIDGE, 47 - 66 MM (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number	47006-47
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There were an additional two variable bridges used in the case.The implants contained two (2) separate descriptions/part numbers & two (2) unique identifying lot numbers.Review of the device history records for all the returned bridges revealed no manufacturing, processing or design related irregularities.The implants were found to be properly manufactured and released in accordance with the device master record.47006-47, variable bridge, 47-66 mm, lot 7826808, mfg'd 5/5/2016.47006-64, variable bridge, 64-101 mm, lot 7293416, mfg'd 12/23/2014.Arsenal bridges are not intended to be disassembled.They are manufactured with a flare at the distal tip of the clamp screw to retain the screw within the implant.Visual inspection under magnification confirmed that the tip was flared as required, but the circularity had been distorted from its manufactured form.It appears the surgeon used excessive force to remove the clamp screw which allowed it to pass thru the clamp and become detached from the implant.
Event or Problem Description
During the surgery, the surgeon tried to cross-link and hook the rod with the bridge.As a result it could not be conducted because the bridges were dissembled, he tried 3 bridges and surgery was delayed 2 hours.

• Brand Name: VARIABLE BRIDGE, 47 - 66 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: 9075692
• Report Number: 2027467-2019-00045
• Device Sequence Number: 2181305
• Product Code: NKB
• UDI-Device Identifier: 00844856073494
• UDI-Public: (01)00844856073494(10)8240601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2019

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: 47006-47
• Device Catalogue Number: 47006-47
• Device Lot Number: 8240601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/17/2019
• 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