MAUDE Adverse Event Report: ALPHATEC SPINE INC SET SCREW, HEXALOBE (TI-6AI-4V ELI); PEDICLE SCREW SPINAL DEVICE

Model Number	22015
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned zodiac set screw is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
An international customer ((b)(6)) reported revision surgery was conducted on (b)(6) 2016 to remove and replace the set screw located on left side of the iliac.The set screw originally implanted on (b)(6) 2015 was found to have backed out of position.During the surgery, it was noticed that the iliac pedicle screw also appeared to be loose.Both the iliac pedicle screw and set screw were replaced in addition to the expansion of the original construct.X-rays taken during the (b)(6) 2016 post-op visit revealed that the set screw located on left side of the iliac had once again backed out of position.Revision to remove and replace the set screw was conducted on (b)(6) 2016.
Additional Manufacturer Narrative
An evaluation of the returned set screw shows significant damage to the underside of the implant.This is common with set screws anchoring in longer constructs (t10 to pelvis).The set screws in these constructs are under extremely high loads because of the moment arm associated with anchoring such constructs.Additionally, since this particular patient suffers from parkinson's, it's likely that healing would not occur as quickly or easily as in other patients.The implants in this construct would likely see the load for a longer period than typically expected.The index surgery occurred nearly 18 months prior to this back-out/disengagement.A previous revision surgery was also conducted due to a back-out at the same location (left side iliac).If the other surgical levels have fused, leaving only the s1 - ilium unfused, it would mean that all compensatory movement is being transferred to this level and with the extensive loading from the fused column above, the unfused level must be carried by the screws at the bottom of the construct.With the addition of a domino connector on the right side of the construct adding additional rigidity to that side, the majority of the stresses and load would be transferred to the left side screw/rod/set screw, leading to the damage seen on the screw and subsequently causing the back-out noted.

• Brand Name: SET SCREW, HEXALOBE (TI-6AI-4V ELI)
• Common Device Name: PEDICLE SCREW SPINAL DEVICE
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6151958
• Report Number: 2027467-2016-00096
• Device Sequence Number: 393170
• Product Code: MNI
• UDI-Device Identifier: 00844856043688
• UDI-Public: 00844856043688
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2016

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?: Yes
• Operator of Device: Physician
• Device Model Number: 22015
• Device Catalogue Number: 22015
• Device Lot Number: 7699401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 01/16/2017
• 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