MAUDE Adverse Event Report: SYNTHES GMBH ORACLE SPACER 45MM X 22MM 9MM HEIGHT/8 DEG ANGLE-STERILE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 08.809.629S

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

Additional procode: mqp.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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 (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, a patient was treated with an oracle implant at the height of l4/5.During the surgery, the implant cracked on the implant holder.A different implant was used.Procedure was completed successfully with minimal delay.Patient status was good.This report is for an oracle spacer 45mm x 22mm 9mm height/8 deg angle-sterile.This is report 1 of 2 for (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.H3, h4, h6: part #: 08.809.629s, synthes lot #: h775144, supplier lot #: n/a, release to warehouse date: december 18, 2018, expiration date: december 1, 2028, manufactured by: elmira.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the oracle cage 45*22 h9 8° peek (p/n: 08.809.629s, lot number: h775144) was received at us customer quality (cq).Upon visual inspection it was observed the complaint device was received broken, and broken fragment was returned attach to mating device¿s jaw.Device failure/defect identified? : yes.Dimensional inspection: a dimensional inspection was not performed on the complaint device due to the post manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed oracle spacer assembly no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint was confirmed since the device was received in broken condition.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: ORACLE SPACER 45MM X 22MM 9MM HEIGHT/8 DEG ANGLE-STERILE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12575953
• MDR Text Key: 274729831
• Report Number: 8030965-2021-08356
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819325272
• UDI-Public: (01)07611819325272
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.809.629S
• Device Lot Number: H775144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: IMPL-HOLDER F/ORACLE CAGE.; IMPL-HOLDER F/ORACLE CAGE
• Patient Age: 60 YR
• Patient Sex: Female