MAUDE Adverse Event Report: SYNTHES (USA) SCR Ø1.5 SELF-DRILL L6 TAN 1U I/CLIP; BONE PLATE

Catalog Number 04.503.226.01C

Device Problems Bent (1059); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reported an event in (b)(6) as follows: it was reported that the patient was implanted with six bone anchor plates and an unknown quantity of 6 mm self-drilling matrix midface screws on (b)(6) 2014.On an unknown date one of the plates, located in the mandible, broke.It was reported that the head of the plate had broken off.Elastic had been used only for a few days.On (b)(6) 2014, a revision procedure was performed to address the broken plate head so treatment could be continued without removing the plate.The surgeon created a temporary solution by milling the plate to make a hook and attached etched plastic dental material to the broken end of the plate.This enabled treatment, which involves pulling/drawing the plate by elastic, to continue.The plastic attachment had been changed twice during (b)(6) 2014 due to failure.During a follow up exam on (b)(6) 2014, the provisional attachment was determined to be working fine.The other five bone anchor plates are reported to be working correctly with no breakage reported.A related complaint ((b)(4)¿reported separately) addresses the broken plate and the initial procedures performed to address it.A revision/explant surgery was performed on (b)(6) 2015 to remove the broken anchor plate and associated screws.A new anchor plate was implanted during this surgery.The revision/explant surgery is addressed in this complaint.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient weight was not provided by reporter.The date when the subject plate broke is unclear.The plate may have broken on (b)(6) 2014¿the same date the first revision procedure was performed, but additional clarification was not provided.This product is manufactured in the usa but for export only and is similar to part number 04.503.226.01 ti matrixmidface screw self-drilling 6mm, common name¿bone plate, device product codes¿jey and dzl.Quantity of screws is unknown.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.No report of a product malfunction, this device cannot be disassociated from the reported adverse event.The reported event required medical/surgical intervention to preclude permanent damage to a body structure.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that:article: 04.500.013 lot.7432188, our investigation of the returned plate has shown, that a part is broken off.The plate shows scratches at the whole part.Unfortunately we are not able to determine the exact cause which has led to this breakage, it is likely that a mechanical overload situation has led to this damage, or the implant was bent in different directions.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.Unknown screws: the visual investigation of the screws has shown some small scratches at the head.No other damages are visible.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

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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: SCR Ø1.5 SELF-DRILL L6 TAN 1U I/CLIP
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4802985
• MDR Text Key: 18089983
• Report Number: 2520274-2015-14092
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.226.01C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention