MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC OPAL SPACER 10MM X 24MM 13MM HEIGHT-REVOLVE; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	08.803.053
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device product code: mqp.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 or Problem Description
It was reported that an oblique posterior atraumatic lumbar (opal) spacer broke during a posterior lumbar interbody fusion that was performed on (b)(6) 2017.As the surgeon was inserting the spacer; when he tried to re-position it, the back corner of the spacer broke off.All the fragments were retrieved.Another opal spacer was used to successfully complete the surgery without any delay.The patient outcome was as expected.This report is for one (1) opal spacer 10 mm x 24 mm 13 mm height-revolve.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: part # 08.803.053, lot # h444443, part mfg date: 08 september 2017, manufacturing location: (b)(4).Part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of opal spacer 10mm x 24mm 13 mm height-revolve product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A product development investigation was performed for the subject device: it was reported that an oblique posterior atraumatic lumbar (opal) spacer broke during a posterior lumbar interbody fusion that was performed on (b)(6) 2017.As the surgeon was inserting the spacer; when he tried to re-position it, the back corner of the spacer broke off.All the fragments were retrieved.Another opal spacer was used to successfully complete the surgery without any delay.The patient outcome was as expected.The returned opal spacer (08.803.053, h444443) is part of the oblique posterior atraumatic lumbar (opal) spacer system indicated for use in patients with degenerative disc disease at two contiguous levels from l2 to s1 whose condition requires the use of interbody fusion combined with supplemental fixation.The returned spacer was found to have a section of it broken off, which confirmed its complaint condition and made its replication inapplicable.The returned spacer was manufactured on 08-sep-17 and drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.No mrrs, ncrs, or actions related to the complaint condition were generated during production of the returned part(s).Review of device history record(s) showed that there were no issues during the manufacture of the product(s), which would contribute to the complaint condition.The material, material properties, and hardness of the returned part(s) were determined to be conforming at the time of manufacture and based on review of the associated/available dhr(s) and based on the details of the complaint and investigation of the returned part(s), additional material/hardness testing is not required.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Based on the available information it is not possible to determine a definitive root cause for the complaint condition.Measurement of the returned spacer was not possible due to post-market damage and in this case measurement of the returned spacer would not add value to the investigation.One of the ways in which spacers can be inserted involves the gentle impacting of implant holders in order to ensure proper placement.It is possible that if the spacer was not properly attached to the implant holder and/or was impacted in an unexpectedly rough manner which exposed it to off-axis forces, it could have contributed to the complaint condition.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: OPAL SPACER 10MM X 24MM 13MM HEIGHT-REVOLVE
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7126657
• Report Number: 2939274-2017-50358
• Device Sequence Number: 1210741
• Product Code: MAX
• UDI-Device Identifier: 10705034754352
• UDI-Public: (01)10705034754352(10)H444443
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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: 08.803.053
• Device Catalogue Number: 08.803.053
• Device Lot Number: H444443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 56