MAUDE Adverse Event Report: SYNTHES ELMIRA OPAL SPACER 10MM X 24MM 12MM HEIGHT-REVOLVE; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	08.803.052
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Device malfunctioned intra-operatively and was not implanted / explanted.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 history records review was conducted.The report indicates that the: part manufacturing date: august 01, 2017.Part number: 08.803.052; lot number: h415569.Original manufacturing location: (b)(4) manufacturing facility.No article / device was returned in order to perform a manufacturing evaluation.A device history record (dhr) review was conducted for the opal spacer 10mmx24mmx12mm height-revolve.The dhr review revealed no complaint-related anomalies.This lot of opal spacers was processed through the normal manufacturing and inspection operations with no nonconformances or rework noted.This order met all dimensional and visual criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.Additionally, a review of the raw material dhr revealed that this lot met all specifications with no nonconformances or rework noted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during a procedure on (b)(6) 2017 and while the surgeon was inserting the opal cage implant, the implant broke during the turning of the insertion.Patients outcome is fine and the surgery was successfully completed.There was no surgical delay reported.This complaint involves one device.Concomitant device reported: insertion handle (part # unknown, lot # unknown, quantity 1).This report s 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.The investigation summary indicates that: the returned spacer was examined and the complaint condition was able to be confirmed as the proximal end of the spacer was found to be broken and missing segments where the implant holder interacts with the device.No definitive root cause was able to be determined.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, drawing review and device history review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The 10mm x 24mm, 12mm height opal spacer (08.803.052) is utilized in the oblique posterior atraumatic lumbar (opal) spacer system.The spacer is indicated for use in patients with degenerative disc disease (ddd) at one or two contiguous levels from l2 to s1 and is intended to be utilized with supplemental fixation.After preparation and trialing, the implant is attached to an opal implant holder (03.803.001 or 03.803.002) which is gently impacted until the spacer is in position.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition, this complaint is confirmed.Device 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: OPAL SPACER 10MM X 24MM 12MM HEIGHT-REVOLVE
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 7037659
• Report Number: 3003506883-2017-10266
• Device Sequence Number: 19171797
• Product Code: MAX
• UDI-Device Identifier: 10705034754345
• UDI-Public: (01)10705034754345(10)H415569
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 08.803.052
• Device Catalogue Number: 08.803.052
• Device Lot Number: H415569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/18/2017
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 154