MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS,PEDICLE SPINAL FIXATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #: this report is for unknown synthes universal spinal system (uss).Part#, lot# and udi # is not available.Device available for evaluation: device is not expected to be returned for manufacturer review/investigation.Pma/510k: this report is for unknown synthes universal spinal system (uss).Pma/510(k) number is not available.Device evaluated by mfr, manufacture date: product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: totterman, a., glott, h., madsen, je.And røise, o.(2006), "unstable sacral fractures: associated injuries and morbidity at 1 year." spine, vol.31 no.18, pages e628-e635 (norway) doi: 10.1097/01.Brs.0000231961.03527.00.The objective of this prospective cohort study is to assess the prevalence and type of additional injuries at the time of injury among patients with unstable sacral fractures treated with internal fixation, and to relate these injuries to medium-term morbidity.Between july 1996 and march 2003, a total of 32 patients (24 male and 8 female) with a mean age of 33 years (range, 16-57 years) underwent reduction and internal fixation.Of these patients, 13 patients underwent triangular lumbosacral fixation using the universal spinal system, uss (synthes, glutz-blotzheim-str.1-3, 4500 solothurn, switzerland).The minimum follow-up was 1-year.The following complications were reported as follows: 29 patients had sensory impairments at follow-up.15 patients reported that the anogenital dermatomes (s3-s5) were affected and 10 patients had involvement of dermatomes proximal to the l5 segment.22 cases, the sensory impairments were partial.2 of 17 patients with neurotrauma had experienced complete recovery.8 patients with no initial signs of neurotrauma had sensory impairments at follow-up, indicating that a significant portion of neurotrauma had been missed initially.14 patients had weakness of the lower extremities, half of them with bilateral findings.The affected segments were ankle dorsiflexors in 6 patients, long toe extensors in 3 patients, ankle plantar flexors in 2 patients, and knee extensors in 2 patients.4 patients had complete paralysis.2 patients had involvement of the t10-l2 segments.2 patients reported that the anal sphincter tonus was reduced.18 patients with sacral fracture whose sensory function were altered.6 patients with spine injury whose sensory function were altered.1 patient with cerebral injury whom the sensory function was altered.1 patient with medullary ischemia whom the sensory function was altered.3 other patients whose sensory function were altered.10 patients with sacral fracture whose motor nerve function were altered.3 patients with spine injury whose motor nerve function were altered.1 patient with medullary ischemia whom the motor nerve function was altered.11 patients with sacral fracture whose mobility were slightly reduced.1 patient with cerebral injury whom the mobility was slightly reduced.4 patients with sacral fracture whose mobility were significantly reduced.1 patient with amputation whom the mobility was significantly reduced.1 patient with spine injury whom the mobility was severly reduced.1 patient with medullary ischemia whom the mobility was severly reduced.5 patients with sacral fracture whose reported voiding function were slightly altered.1 other patient whom the reported voiding function was slightly altered.6 patients with sacral fracture whose reported voiding function were significantly altered or no control.1 patient with spine injury whom the reported voiding function was significantly altered or no control.1 patient with cerebral injury whom the reported voiding function was significantly altered or no control.1 patient with medullary ischemia whom the reported voiding function was significantly altered or no control.1 other patient whom the reported voiding function was significantly altered or no control.3 patients with sacral fracture whose bowel function were slightly changed.1 other patient whom the bowel function was slightly changed.4 patients with sacral fracture whose bowel function were significantly or completely changed.1 patient with spine injury whom the bowel function was significantly or completely changed.1 patient with medullary ischemia whom the bowel function was significantly or completely changed.1 other patient whom the bowel function was significantly or completely changed.8 patients with sacral fracture whose sexual function were altered.2 patients with spine injury whose sexual function were altered.1 patient with medullary ischemia whom the sexual function was altered.1 other patient whom the sexual function was altered.21 patients had pathologic results of the urodynamic test.24 patients reported that the voiding function and urodynamic tests, bladder function was graded changed based on self-assessed.9 asymptomatic patients had urodynamic signs of bladder impairments were observed.2 patients had severly pathologic urodynamics despite only minor subjective complaints.4 patients had difficulty defecating (use of bowel press for fecal emptying).3 patients had urge or reflectory defecation.2 patients had diarrhea.2 patients had colostomy related problems.1 patient had reduced awareness of ampullary filling.1 patient had constipation.3 patients had complete erectile dysfunction.3 patients complained of genital hypo-or anesthesia.8 patients had unilateral and partial genital sensory impairments.4 patients had bilateral genital sensory impairments.3 patients had complete genital sensory impairments.3 patients with complete bilateral saddle anesthesia reported severe sexual problems.2 patients reported complete voluntary and reflectory erectile dysfunction.1 patient had anorgasmia and genital anaesthesia.9 patients had urinary incontinence.6 patients had bladder inertia (use of bowel press).4 patients had bladder inertia (use of self-catheterization).6 other patients had (urge, pollakisuria, intermittent voiding).This report is for an unknown synthes universal spinal system (uss).This is report 1 of 1 for (b)(4).

• Type of Device: ORTHOSIS,PEDICLE SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8566572
• MDR Text Key: 143703290
• Report Number: 8030965-2019-63307
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention