MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721000

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Not Applicable (3189)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection of the returned device found half the threads on opposite sides are completely broken.Shear marks are apparent on the core.The fragments of the threads were not returned.The core and threads were discolored.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.Although no definitive root-cause can be determined, it is possible that the device experienced unintended forces due to over-torque / off-axis tightening.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A female patient, born (b)(6), was treated today ((b)(6) 2019) with the expedium verse 'adavanced' set (orthokit, see screenshot of reservation) at l3-l4.When the correction cap was inserted, it was tilted in the long head of the expedium verse advanced screw so much that the long thread of two screws was defective and a total of 6 correction caps were defective.At the final tightening with torque of the inner adjusting screw in one situation the inner adjusting screw was so defective that it broke.Surgical delay about 1 hour, procedure was completed with modular end caps after they changed two screws.

Manufacturer Narrative

Product complaint # (b)(4).Device manufacture date: correction.

• Brand Name: VERSE CORRECTION KEY
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9327668
• MDR Text Key: 180400030
• Report Number: 1526439-2019-52436
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466132
• UDI-Public: 10705034466132
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199721000
• Device Lot Number: 128220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 90