MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.1MM TI MATRIX SCREW SELF-TAPPING/6MM; SCREW, FIXATION, BONE

Catalog Number 04.511.236.01C

Device Problem No Apparent Adverse Event (3189)

Patient Problems Erosion (1750); Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative 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.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 below: 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.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 underwent 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 with a non-union and exposure of all plates.On (b)(6) 2019, removal of both mandibular plates and screws were performed as well as the genioplasty.During the revision, the surgeon discovered the maxilla was mobile and the matrixmandible screws associated with the trumatch midface/mandible plate were loose.It is unknown if there was a surgical delay.Patient and procedure outcome are unknown.This report is for one (1) 2.0mm ti matrixmandible screw self-tapping 6mm this is report 2 of 4 for (b)(4).Due to a limit of impacted products per complaint, this complaint is a continuation from 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.This report is for an unknown lot number.The udi number and 510k number is unknown.Device received.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.Investigation summary: investigation site: cq zuchwil.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, 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.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

Late entry: this complaint was created due to additional information received on april 22, 2019 in (b)(4), stating that: call log with the product specialist (b)(6) 2019.Dr.(b)(6) removed all components on (b)(6) 2019 put in by dr.(b)(6) on (b)(6) 2018 for exposure of the plates.During the procedure he discovered that the maxilla was mobile and that the screws (04.503.406.01c) lot number: details not known.Quantity: as per case report me18-rar-sul attached total 24 screws associated with the maxilla plate (sd980.014) were all loose.He obtained patient consent and brought her back for splinting, grafting, plates, screws using competitor products on (b)(6) 2019.Part # 04.511.236.01c updated to matrix screws.

• Brand Name: 2.1MM TI MATRIX SCREW SELF-TAPPING/6MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8624009
• MDR Text Key: 145510959
• Report Number: 8030965-2019-64161
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819924093
• UDI-Public: (01)07611819924093
• Combination Product (y/n): N
• PMA/PMN Number: K063790
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.236.01C
• 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