MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN MONO/POLYAXIAL SCREWS; SCREW,FIXATION,BONE

Device Problem Migration (4003)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: scholl, b.M., theiss, s.M., and kirkpatrick, j.S.(2006), short segment fixation of thoracolumbar burst fractures, orthopedics, vol.29(8), pages 703-708 (usa) this study reviews the authors¿ experience with short segment instrumentation and the intermediate fixation of two above and one below, and determines whether the load sharing classifi cation was predictive of failure with either technique.Between 1992 and 2000, a total of 22 patients (14 males and 8 females) with an average age of 30 years (range: 16-52 years) underwent posterior instrumented short segment fusion with iliac bone grafting.6 patients used a miami-moss (depuy acromed, raynham, mass) and 1 patient used an isola (depuy acromed).The average follow-up of 30 months (range: 4-94 months).The following complications were reported as follows: a (b)(6)-year-old male patient had complications and a 14 degree loss of correction.An (b)(6)-year-old male patient had complications, 17 percent loss of height, a 10 degree loss of correction and an additional surgery.A (b)(6)-year-old male patient had complications, 20 percent loss of height and a 5 degree loss of correction.A (b)(6)-year-old male patient had an infection, a 35 degree loss of correction and an additional surgery.A (b)(6)-year-old female patient had complications, 20 percent loss of height and a 28 degree loss of correction.A (b)(6)-year-old male patient had complications, 33 percent loss of height, a 5 degree loss of correction and an additional surgery.A (b)(6)-year-old female patient had complications, a 7 degree loss of correction and an additional surgery.A (b)(6)-year-old male patient had complications, 48 percent loss of height, a 17 degree loss of correction and an additional surgery.A (b)(6)-year-old male patient had infection, 14 percent loss of height, a 4 degree loss of correction and additional surgery.A (b)(6)-year-old female patient had complications, a -8 loss of correction and an additional surgery.A (b)(6)-year-old male patient had complications, 13 percent loss of height and a 24 degree loss of correction.9 patients had implant bending or breakage.4 patients did not require additional surgery and went on to uneventful healing with an average of 14.3 degrees progression of kyphosis.2 had disarticulation of rod/screw construct.1 had a screw pull out slightly.1 had bent screws.5 patients had implant failure and required additional surgery.1 patient had bilateral rod breakage.2 patients had multiple screw breakage.2 patients had hook dislodgement.These 5 patients were successfully revised with anterior strut with posterior spinal instrumentation and fusion (2 patients), removal of hardware (1 patient), revision of posterior short segment instrumentation (1 patient), and extension of posterior instrumentation (1 patient).3 patients developed infections.No patient had neurological complications related to their surgery.1 male patient with a protracted course in the intensive care unit developed sepsis, with a resultant wound infection requiring multiple irrigation and debridements with eventual osteomyelitis and pedicle screw cutout from the vertebra necessitating removal.This patient went on to spontaneous fusion with 37 degree kyphosis across his injury level.The second male patient was lost to follow-up after discharge and returned 20 months later with (b)(6) osteomyelitis.This patient had screw cutout from his cephalad vertebra requiring hardware removal with resultant 40 degree residual kyphosis after spontaneous fusion.The third male patient had extension of his hardware an additional level after early hook dislodgement and was lost to follow-up.He was an alcohol and tobacco abuser who developed osteomyelitis 6 months after his revision surgery that was treated with hardware removal and intravenous antibiotics; he currently has a residual kyphotic deformity of 15 degrees.This report is for a miami-moss (depuy acromed, raynham, mass) and an isola (depuy acromed).This is report 2 of 9 for (b)(4).The complaint involves 29 devices.Due to a limit of impacted products per complaint, this complaint will be captured under 3 separate complaints as listed below: (b)(4).This complaint will include 10 devices - 10 screw/rod construct accessories (1st pc) (b)(4).This complaint will include 10 devices - 4 screw/rod construct accessories, 4 mono/polyaxial screws, 1rod, 1 hook (2nd pc).(b)(4) - this complaint will include 9 devices - 4 screw/rod construct accessories, 2 hook, 2 screw, 1 rod (3rd pc).For the overall complaint, adverse event review activity, mdv activity, and additional information request activity will be documented in (b)(4).

• Brand Name: UNKNOWN MONO/POLYAXIAL SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9654114
• MDR Text Key: 190837740
• Report Number: 1526439-2020-00475
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention