| Catalog Number MB917R |
| Device Problem
Positioning Problem (3009)
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| Patient Problems
Quadriplegia (2449); No Code Available (3191)
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| Event Date 04/07/2017 |
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Event Type
Injury
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3004788213-2019-00335 to 3004788213-2019-00338.
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Event Description
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It was reported that an implant trial and implant trial holder resulted in permanent injury (quadriplegia) as a result of blunt trauma to the spinal cord and the patient lost map sensors during surgery.After losing the map sensors, two artificial disc devices were implanted.A revision surgery was subsequently performed to remove both disc replacement devices of unknown size and replace them with a fusion construct.This is report one of four for this event.
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Manufacturer Narrative
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Additional information in b4, g4, g7, h2, h6: methods, results, and conclusion codes.The product was not returned and no photos were provided, so an evaluation is unable to be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.Without the returned product, the event is non-verifiable.The following section was corrected: h3: product was not returned.
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Event Description
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It was reported that an implant trial and implant trial holder resulted in permanent injury (quadriplegia) as a result of blunt trauma to the spinal cord and the patient lost map sensors during surgery.After losing the map sensors, two artificial disc devices were implanted.A revision surgery was subsequently performed to remove both disc replacement devices of unknown size and replace them with a fusion construct.This is report one of four for this event.
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Manufacturer Narrative
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(b)(4).D11 - medical product: catalog #: unknown, mobi-c trial 13x15 h5mm, lot # unknown, catalog #: unknown, mobi-c implant 15x15 h5 us, lot # unknown, catalog #: unknown, mobi-c implant 15x15 h5 us, lot # unknown.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : not returned by patient.
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Event Description
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No further event information available at the time of this report.
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Event Description
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It was reported that an implant trial and implant trial holder resulted in permanent injury (quadriplegia) as a result of blunt trauma to the spinal cord and the patient lost map sensors during surgery.After losing the map sensors, two artificial disc devices were implanted.A revision surgery was subsequently performed to remove both disc replacement devices of unknown size and replace them with a fusion construct.This is report one of four for this event.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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Event Description
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It was reported that an implant trial and implant trial holder resulted in permanent injury (quadriplegia) as a result of blunt trauma to the spinal cord during a c4-5 and c5-6 implantation surgery.The c4-5 portion of the surgery was complicated by dissection of several layers of osteophyte complex that had been producing severe central canal compression.Even with this distraction, the 5mm spacer that was implanted was reported to be a very tight fit.A trial implant was used to test the disc space at which point a loss of motor signals was noted.The spacer was removed and subsequently there was a loss of sensory potentials as well.The decision to install a mobi-c implant was made and the wound was closed.A revision surgery was subsequently performed to perform posterior laminectory decompression from c4-6 and removal of implants and replace with a fusion construct.After the mobi-c was removed at c4-5, a 5mm cage was installed (the smallest height available); this did not provide any significant distraction to the space.The mobi-c implant was c5-6 was also removed and replaced with a 5mm spacer; this provided enough resistance to have good contact but no significant distraction.A two-level plate with six 14mm screws were installed.The wound was closed and the patient was flipped over for the posterior portion of the procedure.The patient was noted to have mild compression of the thecal sac under c5 and at c5-6, as well, and moderatly to minimum at c4-5.After decompression it was noted pulsations did return to the dura.The wound was closed.This is report one of four for this event.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Summary: the complaint is unrefuted for four (4) of four (4) unreturned mobi-c products (pn: mb917r (1ea), unk mobi-c trial (1ea), mb3575 (2ea)) for the failure of patient harm.The product was not returned and no photos were provided.Medical records were provided, but do not provide further information regarding the events during the surgery.Potential cause: since the parts were not returned, an effective root cause can't be established.Dhr review and related actions: dhr was not able to be reviewed due to lack of reported lot number.This event is not related to any current actions or recalls or product holds.Device use and compatibility: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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Event Description
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It was reported that an implant trial and implant trial holder resulted in permanent injury (quadriplegia) as a result of blunt trauma to the spinal cord during a c4-5 and c5-6 implantation surgery.The c4-5 portion of the surgery was complicated by dissection of several layers of osteophyte complex that had been producing severe central canal compression.Even with this distraction, the 5mm spacer that was implanted was reported to be a very tight fit.A trial implant was used to test the disc space at which point a loss of motor signals was noted.The spacer was removed and subsequently there was a loss of sensory potentials as well.The decision to install a mobi-c implant was made and the wound was closed.A revision surgery was subsequently performed to perform posterior laminectory decompression from c4-6 and removal of implants and replace with a fusion construct.After the mobi-c was removed at c4-5, a 5mm cage was installed (the smallest height available); this did not provide any significant distraction to the space.The mobi-c implant was c5-6 was also removed and replaced with a 5mm spacer; this provided enough resistance to have good contact but no significant distraction.A two-level plate with six 14mm screws were installed.The wound was closed and the patient was flipped over for the posterior portion of the procedure.The patient was noted to have mild compression of the thecal sac under c5 and at c5-6, as well, and moderatly to minimum at c4-5.After decompression it was noted pulsations did return to the dura.The wound was closed.This is report one of four for this event.
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