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

Model Number	08.803.053
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Additional device product code: mqp.Incident occurred intraoperative.Device was not implanted/explanted.Patient code: the opal spacer broke into multiple pieces and it is unknown if any pieces were left in the patient.Device history records review was completed for part# 08.803.053, lot# h365208.Manufacturing location: (b)(4), manufacturing date: may 16, 2017.No non conformance reports (ncr) was generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A review of device history record (dhr) completed for incoming lot of tan pin diameter 1.2 mm (part number 889.961.05, lot h278304), raw material lot of tial nbri2.50 (part number 21038, synthes lot number 9983106), raw material lot of tial nbri2.50 raw material (part number 21038, synthes lot number 9983106).No non conformance reports (ncr) were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.A visual inspection, device history records review and drawing review were performed as part of this investigation.Four fragments of the opal spacer implant were returned.Some of the fragments were missing.The fragments were observed to be in severely bad condition and show indication of additional damage other than intra-operative breakage which they may have suffered during the fragment removal process.The complaint condition could not be replicated as the returned device was in a broken condition.This complaint is confirmed.Relevant product drawings were reviewed.Feature measurements could not be verified accurately due to device being severely damaged.The design and materials were found to be appropriate for the intended use of these devices.Exact root cause could not be determined based on available information.Opal spacer system technique guide was reviewed.Technique guide recommends gentle impacts on the end of the implant holder for positioning of the spacer.Surgeon may have applied excessive force during this step.On the other hand, proper steps should be followed to release the spacer from the implant holder.Hospital staff may have used excessive force to separate spacer from the holder.Additionally, the device shows signs of sustaining added damage other that intra-operative breakage.This may have occurred during fragment removal process.Hence, the exact root cause could not be determined.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 on (b)(6) 2017, patient underwent a transforaminal lumbar interbody fusion (tlif) at l2 to l4.During the procedure, the oblique posterior atraumatic lumbar (opal) spacer broke into pieces.While attempting to remove the two (2) broken pieces of the opal spacer with a kerrison rounger, additional fragments were generated.All fragments were removed.A new spacer was used to successfully complete the surgery with no delay.The patient outcome was reported as fine.It was reported that all fragments were removed.On (b)(6) 2017, manufacturer investigation noted that four of the fragments were returned but some of the fragments are missing.This report is for one (1) opal spacer height-revolve.This is report 1 of 1 for (b)(4).

• Brand Name: OPAL SPACER 10MM X 24MM 13MM 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: 6770242
• Report Number: 3003506883-2017-10151
• Device Sequence Number: 11205669
• Product Code: MAX
• UDI-Device Identifier: 10705034754352
• UDI-Public: (01)10705034754352(10)H365208
• 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
• Report Date (Section B): 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 08.803.053
• Device Catalogue Number: 08.803.053
• Device Lot Number: H365208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/07/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 138