MAUDE Adverse Event Report: ALPHATEC SPINE INC PRE-CONTOURED / C.P. TI ROD 5.5MM X 4.5CM (CP-TI GRADE 4); PEDICLE SCREW SYSTEM

Model Number	73600-045
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The illico pre-contoured rod is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
About the three months after the surgery, the reoperation [sic] was performed because confirmed [sic] that the disk space of the patient had been pressed.Doctor retrieved out [sic] all implanted screws and rods from the patient.Then he found out that the rod which had been implanted on the right side was broken.At the current moment, no health injury of the patient was confirmed by this incident.
Additional Manufacturer Narrative
An evaluation of the suspect device revealed no manufacturing or processing related irregularities.The implant was found to be properly manufactured and released in accordance with design specifications.Examination of the post-op x-rays shows that both rods were extending beyond the pedicle screws on both the cranial and caudal sides, indicating full rod contact was achieved with the construct.In the x-rays taken prior to revision surgery, there is no indication that the rod is broken; the construct appears intact and the rod appears to be correctly positioned.The angles of the pedicle screws on the right side (the side of the rod failure) do appear altered, however, with the pedicle screws having changed angulation notably due to the collapse of the disc on that side.The interbody devices have also pivoted.This indicates that the construct was under a significant amount of load which appears to be enough to change the angulation of the pedicle screws.Therefore this seems to indicate that the collapse of the disk occurred first, which then led to stresses in the construct causing the rod to fail.

• Brand Name: PRE-CONTOURED / C.P. TI ROD 5.5MM X 4.5CM (CP-TI GRADE 4)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5455016
• Report Number: 2027467-2016-00006
• Device Sequence Number: 402628
• Product Code: NKB
• UDI-Device Identifier: 00844856043503
• UDI-Public: 00844856043503
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2016

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: 73600-045
• Device Catalogue Number: 73600-045
• Device Lot Number: 690315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2016
• Supplement Report FDA Received Date: 04/13/2016
• 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
• Patient Age: 72 YR