MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC LINESIDER DUAL LEAD CANNULATED SCREW 6.5X50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	LS-SC7G6550
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The reported event was unable to be confirmed due to limited information received from the customer.The device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A review of the complaint history determined that no further action was required as no trends were identified.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur, and risks are addressed in risk documentation.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Integrity implants will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent an initial one-level posterior fixation procedure on an unknown date.Subsequently, the patient underwent a revision procedure due to posterior pull-out of the l4 pedicle screw away from the bone, post-operatively.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: LINESIDER DUAL LEAD CANNULATED SCREW 6.5X50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• MDR Report Key: 11737903
• Report Number: 3012797630-2021-00012
• Device Sequence Number: 4244818
• Product Code: NKB
• UDI-Device Identifier: 00818613024432
• UDI-Public: (01)00818613024432
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K190360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: LS-SC7G6550
• Device Catalogue Number: LS-SC7G6550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/28/2021
• 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: Required Intervention
• Patient Age: 49 YR