MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONN O/O SD TOP NTCH 5.5X5.5 T; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	179771555
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination found that the tulip head threads on the connector were torn.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 conn o/o sd top ntch 5.5 x 5.5 t cannot be determined.Noted damage suggests that inadvertently cross threading of the set screw occurred upon insertion into the tulip head of the connector.The root cause of the set screw¿s drive feature stripping could not be determined from the sample and the information provided.A potential root cause may be not fully inserting the associated driver into the set screw during tightening.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 or Problem 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: CONN O/O SD TOP NTCH 5.5X5.5 T
• Common Device Name: 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: 9265578
• Report Number: 1526439-2019-52351
• Device Sequence Number: 419253
• Product Code: NKB
• UDI-Device Identifier: 10705034077819
• UDI-Public: 10705034077819
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 179771555
• Device Lot Number: NW176122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 75