MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 179702000

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Visual examination found that the threads on the set screw were completely torn off.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.With the information provided, a definitive root cause for the torn threads on the single-inner set screw cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head.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

Dr (b)(6), expedium si set screws ¿ 186715000, open-closed connector - 179755155: repeatedly stripping.Procedure was completed by using multiple locking screws.No patient complications.Operation was completed as expected.15 minute delay to the procedure.

• Brand Name: SINGLE-INNER SETSCREW
• 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
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9265726
• MDR Text Key: 184868759
• Report Number: 1526439-2019-52355
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034064307
• UDI-Public: 10705034064307
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 179702000
• Device Lot Number: ARFDG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Date Manufacturer Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 75