MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES; PLATE, FIXATION,BONE

Catalog Number UNK - PLATES: TRAUMA

Device Problem Use of Device Problem (1670)

Patient Problems Skin Erosion (2075); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).This report is for an unknown plates: trauma/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthe rep.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.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

"evice" report from synthes reports an event in (b)(6) as follows: it was reported that an adverse incident with a psi, lot and reference is unknown.The case number of the psi is: (b)(4) a peek plasty psi with 3 mini plates and 6 screws was implanted (we don't know if the screws are from another commercial house).On (b)(6) 2012 the patient presented a small asymmetry in the plasty psi, as well as in one of the screws of the titanium lower plate that had been released.The same cranioplasty is replaced again, but 4 months later another of the screws is released with the result of another intervention and has an infection altering the bone and osteosynthesis material.On (b)(6) 2012 cranial ct scan is performed again because plasty psi mobility is objective.On (b)(6) 2012 is re-operated by placing the same plasty psi and using a greater number of plates to ensure anchoring.On (b)(6) 2014, a skin lesion occurs due to a continuous rubbing by a screw and is intervened again and with the same plasty psi.The plasty psi does not fit 100% correctly, but they decide not to change it.On (b)(6) 2018 placement of 6 new plates.The patient experience a post-op device malfunction, adverse event, such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing, not well fixation.In addition, the patient require revision surgery, unknown if the device was explanted.Patient consequence were a clinical outcome experienced by the patient (infection, inflammation, infection, pain, and re-interventions, x-rays, additional procedures, prescriptions, otc, revision was required.Concomitant device reported: unknown screws (part #: unknown, lot #: unknown, quantity #: unknown), unknown plates (part #: unknown, lot #: unknown, quantity #: unknown).This complaint involves three (3) device.This report is for one (1) unk - plates.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.E3: reporters state: (b)(6).H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: UNK - PLATES
• Type of Device: PLATE, FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9507231
• MDR Text Key: 188357759
• Report Number: 8030965-2019-71337
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PLATES: TRAUMA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention