MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 9X90MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179704990

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Visual examination found that the threads on the poly screw¿s tulip head had become 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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the tulip head threads becoming torn off cannot be positively determined.However, noted damage suggests that inadvertently cross threading occurred.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 and no systemic trends were found, 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

Screw was inserted with correct screw driver and no issues.Rod was placed in construct and locking caps were inserted.The locking caps for the sai screw could not be tightened although rod seemed to be seating well in screw head.A second locking cap was taken trying again to lock it.The it was realized that the issue was with the screw and not the locking cap.Accordingly the screw was replaced with a new one and everything could be completed without a problem.Patient consequence?: no.Action taken for procedure:new screw was inserted.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.

• Brand Name: VIPER TI SAI POLY 9X90MM
• 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: jason busch ; 325 paramount dr.; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7752082
• MDR Text Key: 116079923
• Report Number: 1526439-2018-50737
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034265865
• UDI-Public: (01)10705034265865
• Combination Product (y/n): N
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179704990
• Device Catalogue Number: 179704990
• Device Lot Number: TBTZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1