MAUDE Adverse Event Report: ALPHATEC SPINE INC ZODIAC COCR STRAIGHT ROD 5.5 X 60 CM (BIODUR CCM PLUS ALLOY); PEDICLE SCREW SPINAL DEVICE

Model Number	62005-60
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information provided by the international customer revealed this patient has previously underwent two (2) prior revisions surgeries.Both cases ((b)(6) 2016) were for the same type of event which occurred at the same location (left side iliac).The root cause was determined to be non-fusion/healing caused stresses and load to be transferred to the area of the back out the axial connector was implanted during the first revision surgery on (b)(6) 2016.While the surgeon was bending the rod for the expansion of the construct, the rod fractured and broke.The axial connector was utilized to reconnect the broken rod for the extension.The use of an axial connector significantly increases the rigidity of the construct in the segment where the connector is used, as a result, much higher loads are transferred to the rod segments on either side of the connector.Since, this particular patient suffers from parkinson's, it's likely that healing would not occur as quickly or easily as in other patients, and therefore the implants in this construct would likely see the load for a longer period than typically expected.Given the high loads and stress concentration on either side of the axial connector, the rod was likely experiencing higher loads than normal.Systems such as the zodiac spinal fixation are typically intended for temporary fixation to provide stabilization during the development of fusion/healing and not intended for permanent implantation.If healing has not occurred; without solid bone fusion, these devices cannot be expected to support the spine indefinitely and may fail due to bone-metal interface, metal or bone failure.If healing has occurred; the devices should be removed after complete healing.Devices, which are not removed after serving their intended purpose may bend, dislocate, or break.
Event or Problem Description
An international customer ((b)(6)) reported that revision surgery was conducted on (b)(6) 2017 to remove a zodiac rod which had fractured and broke.

• Brand Name: ZODIAC COCR STRAIGHT ROD 5.5 X 60 CM (BIODUR CCM PLUS ALLOY)
• Common Device Name: PEDICLE SCREW SPINAL DEVICE
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6570700
• Report Number: 2027467-2017-00031
• Device Sequence Number: 133598
• Product Code: MNI
• UDI-Device Identifier: 00844856049475
• UDI-Public: 00844856049475
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2017

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: 62005-60
• Device Catalogue Number: 62005-60
• Device Lot Number: 658772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2013
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/16/2017
• 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