MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM; BONE PLATE

Catalog Number 04.511.206.01C

Device Problem Device Slipped (1584)

Patient Problems Erosion (1750); Bone Fracture(s) (1870); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional patient identifier: (b)(6).Device is not expected to be returned for manufacturer review/investigation.(b)(4).The screw delivered from synthes to customer (through materialise) are all delivered in an unsterile condition.Based on this no investigation will be done on those from synthes side.We have forwarded the received information to the materialise for investigation, as they are responsible for development of plate and screw connection, find the statement as follows: for this complaint, the device history record was reviewed.The implant were designed and manufactured correctly.It is clear from the images that the patient had a mandible distraction and a lefort i before this case ((b)(4)).Potentially, the soft tissues and the bone tissue affected by these previous surgeries are less healthy and strong that the tissues on the other locations.If the tissues do not heal as easily or fast than before, the plates could get exposed.This would also explain why the maxilla was still mobile after the second revision surgery.As no internal root causes were found, patient condition is the most likely root cause.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient had the first revision surgery due to loosening of the matrixmandible screws from the maxillary plate and fibrous union of the maxilla.Initially, the patient had implantation on (b)(6) 2018.However, on (b)(6) 2018, the patient presented a non-union with exposure of all plates that were implanted.Thus, removal of both mandibular plates and screws were performed as well as the genioplasty plate and screws were extracted on (b)(6) 2019.During the revision, the surgeon discovered that the maxilla was mobile and that all the matrixmandible screws associated with the trumatch midface/mandible plate were all loose.It is unknown if there was a surgical delay.Patient and procedure outcome was unknown.(b)(4) captures (1) midface mandible plate and (24) mandible matrix screws that were loose and (5) matrix screw for genioplasty plate which had nonunion and exposed.While (b)(4) captures the (24) matrixmandible screws for right and left mandible and (3) trumatch midface mandible plate mini that had malunion and exposed.This report is for one (1) 1.85mm ti matrix screw self-tapping 6mm.This is report 4 of 10 for complaint (b)(4).

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.Device was used for treatment, not diagnosis.Visual inspection: upon visual inspection no damages could be observed on the received screws.Summary: our investigation has shown, that the reported complaint condition is unconfirmed as the reported complaint condition could not be replicated due to the good condition of the received devices.Furthermore, we can exclude a malfunction of our devices as within the investigation results from materialise the potentially root cause has already been identified.Extract from the investigation report (see also attached final report file ¿c-med-19-4292_encrypted_.Pdf¿ from materialise at pc level), which does document the root cause as follows: ¿the soft tissues and the bone tissue affected by these previous surgeries are less healthy and strong that the tissues on the other locations.If the tissues do not heal as easily or fast than before, the plates could get exposed.This would also explain why the maxilla was still mobile after the second revision surgery.As no internal root causes were found, patient condition is the most likely root cause.¿ the root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.

• Brand Name: 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8629029
• MDR Text Key: 145678936
• Report Number: 8030965-2019-64266
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819358140
• UDI-Public: (01)07611819358140
• Combination Product (y/n): N
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.206.01C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Date Manufacturer Received: 05/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention