MAUDE Adverse Event Report: ORTHO DEVELOPMENT PAGODA; PEDICLE SCREW

Model Number	752-6540-26A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a surgeon performed a plif at l4-l5 and fixed screws and rods in a bilateral construct.On (b)(6) 2019, an x-ray determined that one of the rod on the left side had completely slipped out of the construct.On (b)(6) 2019, the surgeon revised the left side by removing the hardware and implanting new screws and rod.
Additional Manufacturer Narrative
Visual examination revealed thread damage from cross-threading which reduced the rod grip strength.A review of the device history was conducted and no issues were identified during the manufacturing and release of the product that could have contributed to the customer complaint.There is no evidence to indicate the parts were out of specification or damaged.This cannot be confirmed as a manufacturing error.

• Brand Name: PAGODA
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 8634722
• Report Number: 1722511-2019-00014
• Device Sequence Number: 1643748
• Product Code: NKB
• UDI-Device Identifier: 00822409023288
• UDI-Public: (01)00822409023288(17)230917(10)A200341
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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 Expiration Date: 09/17/2023
• Device Model Number: 752-6540-26A
• Device Lot Number: A200341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR