MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 8X80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179704880

Device Problem Break (1069)

Patient Problems Pain (1994); Spinal Column Injury (2081)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2017, the tlif surgery for adult spinal deformity (asd) was performed by using the expedium pus system (sacral-alar-iliac fixation).The fixed site was s2 ai.On (b)(6) 2018, it was reported that the screw (179704880, part#: unk) had been broken in the sacroiliac joint, which was noticed later through the x-ray photos taken around three months after the tlif surgery.The (b)(6) male patient has a pain on the opposite side of the site where the screw in question was broken.No causal relation was reported between the broken screw and the site where he feels a pain.No further information has been provided by the hospital.

• Brand Name: VIPER TI SAI POLY 8X80MM
• 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 drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7784113
• MDR Text Key: 117131791
• Report Number: 1526439-2018-50789
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034265728
• UDI-Public: (01)10705034265728
• Combination Product (y/n): N
• PMA/PMN Number: K111571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179704880
• Device Catalogue Number: 179704880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• 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?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR