MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 6.0X40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199725640S

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 the spine fusion was performed on (b)(6) 2019 to fix the patient¿s spine (location was unknown).During the surgery, when final tightening of the 1 out of the 20 screws, the topnotch of the screw was broken (about 2 threads together with the tab) when the surgeon broke the tab from the screw with the tab breaker (p/n was unknown).The broken fragment remained in the tab breaker.The surgeon confirmed that there was no broken fragment remained in the patient¿s body under x-ray.The surgeon commented that the tension was applied enough although the topnotch was broken.There was no surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.

Manufacturer Narrative

Product complaint #
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> (b)(4).Udi: (b)(4).The screw was not returned for evaluation.Only the extended tab was returned.Visual inspection of the extended tab found that about two threads of the screw head (top notch interface) were broken together with the extended tab.The fracture analysis report notes that the uniform surface of the fractured surface indicates that the top-notch interface underwent a static failure.The absence of rotational deformation and a termination site implies that the top-notch interface was broken under a cantilever force.A review of the device history record could not be performed as only one of the extended tabs of the screw were returned and the remaining device was not returned.The root cause of the two threads of the screw head (top notch interface) breaking together with the extended tab cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a probable root cause is static overload failure due to a single, sudden, unexpectedly high force placed on the top-notch interface.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.

• Brand Name: 5.5 EXP VERSE CAN SCR 6.0X40
• 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: 8343960
• MDR Text Key: 136281857
• Report Number: 1526439-2019-51355
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034440668
• UDI-Public: (01)10705034440668
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199725640S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other