MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. N/A; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	7576545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Radiographic image review results: single intra-op image for l5-s1 fixation or l4-l5 is provided.Detail regarding level is not provided.Single ap image shows a retained screw shank interior to the replacement screw in the lower vertebral body.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from hcp via manufacturing representative regarding patient with deformity for spinal therapy.Patient demographics: gender- male, date of implant: unknown date, date of explant: (b)(6) 2020, device return status: partially explanted.It was reported that on an unknown date, post-op, the screw head of implanted product was broken.Revision surgery was performed on (b)(6) 2020 to remove the broken screw and replaced with another size of screw.It was partial explant.Only screw head could be ex-planted and threaded portion was still inside the patient.Update received on 21 jun 2020: patient demographics: weight- (b)(6) kg, procedure involved: percutaneous.There was no patient complication as a result of this event.There was no plan to remove the threaded portion of the screw from patient body.

• Brand Name: N/A
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10216544
• Report Number: 1030489-2020-00759
• Device Sequence Number: 2404916
• Product Code: KWP
• UDI-Device Identifier: 00885074031156
• UDI-Public: 00885074031156
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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: Health Professional
• Device Model Number: 7576545
• Device Catalogue Number: 7576545
• Device Lot Number: H5396323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 07/01/2020
• 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 Weight: 90