MAUDE Adverse Event Report: SYNTHES GMBH SELF TAPPING SCREWS; SCREW, FIXATION, BONE

Model Number 214.XXX

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

The plate has broken per x-ray (b)(6) 2022, requiring replacement; surgery to be done (b)(6) 2022.One of the screws also broke.Are these items made from steel or titanium? two x-ray pictures uploaded may be of poor quality, taken (b)(6) 2022, one is from 4-week post op follow up, other is from (b)(6) 2022 follow up, per the chart, the implant is: plate 7 hole condylar 95 degree 70mm/124mm, implant type: plate implanted area: femur, laterality: left implanted on: (b)(6) 2021, number implanted:1, implanted by: (b)(6), md implanted at: (b)(6); status: implanted, manufacturer: synthes cmf (formerly maxillofacial) model number: 23774, lot number: na.All 7 self tapping screws (only one broken) are also synthes, models 214.Xxx (last three numbers vary with screw size).Fda safety report id# (b)(4).

• Brand Name: SELF TAPPING SCREWS
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH
• MDR Report Key: 13307192
• MDR Text Key: 284315587
• Report Number: MW5106820
• Device Sequence Number: 2
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/15/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 214.XXX
• Patient Sequence Number: 1
• Treatment: APPLE CIDER VINEGAR; CALCIUM; CELECOXIB; CITALOPRAM ; CO-Q10; GABAPENTIN ; GLUCOSAMINE/CHONDROITIN; LUTEIN ; MANGANESE ; MSM; NEURIVA; OXYCODONE; SAW PALMETTO; VITAMIN B STRESS COMPLEX ; VITAMIN C; VITAMIN D ; ZEAXANTHIN
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White