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 Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) the device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2019, the patient underwent revision surgery due to the rod that was broken bilaterally and the distal screws were loosened.Broken ends of rod catalog # 1797-62-480, verse screw, 1997-21-750 x qty 1, verse screw 1997-21-745 x qty 1 and 9.0x90mm sai screws 1797-04-990 x qty 2 were all removed to revise.A 12.0x100mm screw, 1797-12-399 was removed with pliers due to the first of two screwdriver tips breaking.This screw was not recovered to return.There were no fragments generated.It is unknown if there were surgical delay.The patient and procedure outcome was unknown.This complaint involves six (6) devices.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Device was not returned for evaluation.A review of the device history record could not be performed as the lot number is unknown.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.This complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8821841
• MDR Text Key: 152048641
• Report Number: 1526439-2019-51872
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034265865
• UDI-Public: (01)10705034265865
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention